FOOD AND DRUG ADMINISTRATION
Science Board

Meeting

	April 21, 2000
	8:30 a.m.

U.S. FDA Building
CDER Conference Room
Room 1066
5630 Fishers Lane
Rockville, Maryland

Members of the Science Board to the FDA

Robert S. Langer, ScD. (Chair)
Massachusetts Institute of Technology

Charles A. Sanders, M.D.
Glaxo, Inc. (Retired)

Rita Colwell, Ph.D., D.Sc. (Hon.)
Director, National Science Foundation 

Marion Nestle, Ph.D., M.P.H.
New York University, Professor and Chair
Department of Nutrition and Food Studies

Owen Fennema, Ph.D. Professor Emeritus
Department of Food Science, University of Wisconsin

Martin Rosenberg, Ph.D.
Senior Vice President and Director
SmithKline Beecham Pharmaceutical
Research and Development 

Edward M. Scolnick, M.D., President
Merck Research Laboratories

Robert M. Nerem, Ph.D., Professor and Director,
Institute of Bioengineering and Bioscience
Georgia Institute of Technology

Harold Davis, D.V.M., Ph.D.
Amgen

Marion W. Anders, D.V.M., Ph.D. 
Professor and Chair
Department of Pharmacology
University of Rochester

Michael P. Doyle, Ph.D., 
Professor and Department Head
Department of Food Science and Technology
Center for Food Safety and Quality Enhancement
University of Georgia

Presenters and Meeting Participants

Bernard A. Schwetz, Ph.D., Acting Deputy Commissioner, FDA, and Senior Advisor for Science

Robert Buchanan, Senior Science Advisor and Director, Office of Science, CFSAN 

Steve Sundlof, Ph.D., Director of the Center for Veterinary Medicine, FDA 

Dan Casciano, Ph.D., Acting Director of NCTR

David Feigel, Ph.D., Director of the Center for Devices and Radiological Health

Dennis Baker, Ph.D., Associate Commissioner for Regulatory Affairs

David Lau, Ph.D., microbiologist

Joseph Levitt, Director, CFSAN

Margaret Miller, Ph.D., OWH

Suzanne Fitzpatrick, Ph.D., FDA 

Linda A. Suydam, Senior Associate Commissioner, FDA 

Mary Babcock, Director, OHRM, FDA 

Alan M. Rulis, Ph.D., Director, Office of Premarket Approval, CFSAN 

Dennis Keefe, Ph.D., Assistant to the Director of
Premarket Approval, CFSAN 

Agenda

Introductory Remarks of Dr. Jane Henney, Commissioner of Food and Drugs  
	Presented by Dr. Schwetz	13

Science Board Report on the Review of Research at 
Center for Food Safety and Applied Nutrition 	30
	Dr. Owen Fennema, Professor Emeritus, Department of Food Science, University of Wisconsin

FDA Response	44
	Dr. Robert Buchanan, Senior Science Advisor and Director, Office of Science, CFSAN 

CFSAN's Dietary Supplements Strategic Plan	50
	Mr. Joseph Levitt, Director, CFSAN, FDA 

Overview of the Office of Women's Health (OWH) Scientific Research Program	172
	Dr. Margaret Miller, Manager, Scientific Programs, OWH

Joint FDA and Industry Training	205
	Dr. Suzanne Fitzpatrick, Office of the Senior Advisor for Science, FDA 

Open Public Comment	234

Strategies for Maintaining Quality of Science at FDA	234
	Dr. Bernard A. Schwetz, Acting Deputy Commissioner, FDA, and Senior Advisor For Science, FDA

	Leveraging resources	235
		Dr. Linda A. Suydam, Senior Associate Commissioner, FDA 

	Retention and recruitment of scientists	254
	Flexibility of the profile of scientists
	Training, retraining of scientists
	Peer Review of Scientists
		Mary Babcock, Director, Office of Human Resources & Management Services (OHRM)

	Hiring to support the Science Base of the CFSAN Food Ingredient Safety Program	320
		Dr. Alan M. Rulis, Director, Office of Premarket Approval, CFSAN 
		Dr. Dennis Keefe, Assistant to the Director of Premarket Approval, CFSAN 

Concluding Discussion:  Further Direction for the Board	342

	P R O C E E D I N G S
		DR. SCHWETZ:  Good morning to all of you.  In a moment of quietness, I'll take the opportunity to get everybody's attention.
		Good morning and welcome to the meeting of the Science Board.  For those of you who are beyond the podium, I won't be able to see you and you won't be able to see some of us up in the front here; and if you want to move now to get a better view, that's probably why those seats are open right there.
		Let me open by extending a heartfelt and sincere apology.  I just got a phone call from Dr. Henney's office just a few minutes ago saying that she was sick, and it was the kind of thing that's been going around in our office for the last few days, and people are out for a day or two at that time.  
		Let me assure you, that as we had prepared for this meeting, Dr. Henney was very thoroughly involved in the preparation for this meeting because this was her first meeting with the Science Board.  I can only tell you that she must be pretty sick to not be here this morning.
		She is going to call in later. If she feels good enough to be here, she'll be here; if not, you're stuck with me for the day.
		I want to introduce the Board Members and other people around the table, but there are some other things that we need to do first.  My first introduction is Sue Bond, the Exec Sec for the Science Board, and Sue has some items of business that we need to talk about before we get in to the rest of the meeting.
		Sue?
		MS. BOND:  I just have some housekeeping items for you, just to let you know that we have some telephones in the suite next door, if anybody needs to make telephone calls; and there's also a public telephone out by the guard's desk.  And the restrooms are right outside of this room.  There is also a break area there with soda machines and snacks, and we also have snacks and coffee over here.
		We have one scheduled break, in the morning, at 10:30, but we don't have a scheduled break in the afternoon.  We do have some energy-lifter type refreshments coming in the afternoon to help you, and we have lunch from 12 to 1.  But we're going to ask that everybody ‑‑ during the lunch, we're going to have a luncheon for the Science Board members.  So if the public can vacate the room, we have a cafeteria next door and we have a break room next door for lunch.
		I think that's it for housekeeping.  If anybody needs anything, just let me know.
		DR. SCHWETZ:  Thank you, Sue.
		Let me introduce the members of the Board, and then the people around the table beyond the Science Board members.
		Let me first introduce our chair, Dr. Robert Langer.  Bob is Professor of Chemical and Biomedical Engineering at Massachusetts Institute of Technology, with expertise in the area of biomaterials.  He is a member of the National Academy of Sciences, National Academy of Engineering, and the Institute of Medicine.
		While he has been on the Science Board since 1995, this is the first time that Bob is serving as the chair; he served as alternate chair for Dr. Kipnis a couple of times, but at this time this is the first meeting since Bob has assumed responsibility as the chair of the Science Board.  So Bob, we're very pleased to have you serve that function for us.
		Then going from my left around the table, Dr. Drag Anders is Professor and Chair of the Department of Pharmacology in the Department of Anesthesiology at the University of Rochester.  Expertise in pharmacology, metabolism and toxicology.  And while this is the first year that Drag is on the FDA Science Board, he's been on the Science Advisory Board for NCTR for a number of years, and for the recent years has been serving as the chair of the NCTR Science Advisory Board.  So Drag comes with that expertise and experience as having been the chair of one of the boards for one of our centers.
		Dr. Owen Fennema is Professor Emeritus of the Department of Food Science at the University of Wisconsin, with expertise in food science and biochemistry.  Served as a member of the FDA Food Advisory Committee through 1999 and served as chair of the subcommittee for the peer review of CFSAN's research.  This is his first year on the Science Board of the FDA.
		Marion Nestle, Professor and Chair of the Department of Nutrition and Food Studies at New York University.  Expertise in food and nutrition policy, bacteriology, molecular biology; has been a consumer representative to our FDA Science Board since 1998.  Prior to that, Dr. Nestle served on the FDA Food Advisory Council and several department advisory boards; and she was a member of the CFSAN peer review team.
		Dr. Harold Davis, Senior Director of Toxicology at Amgen, with experience in toxicology and pathology.  And while this is, it's Harold's first year on the FDA Science Board, he has served on the NCTR Science Advisory Board for a number of years; and is currently helping with the FDA search committee for the Director of NCTR.
		Dr. Ed Scolnick, President of Merck Research Laboratories with expertise in biochemical sciences; member of the Institute of Medicine; has held numerous academic appointments and brings a strong industry background to our Board.  This is the first year that Ed is on the Science Board.
		Dr. Rita Colwell hasn't shown up this morning yet; I'm hoping that she will still come.  Director of the National Science Foundation with expertise in marine biology.  Served as member of our Science Board since 1997.
		Dr. Robert Nerem, Professor and Distinguished Chair of Medicine at the George Woodruff School of Mechanical Engineering, Georgia Institute of Technology.  Member of the Institute of Medicine.  Expertise in bioengineering and bioscience, and this is his first year on the Science Board of the FDA.
		Dr. Martin Rosenberg, Senior Vice President and Director of Smithkline Beecham Pharmaceutical Research and Development.  Expertise in anti-infectives and microbiology.  This is his first year on our Science Board, but he also currently serves on the Science Advisory Board for NCTR.
		And Mike Doyle isn't here.  Mike Doyle is a professor ‑‑ and I'm hoping that both of these people will still be with us today.  Dr. Doyle is Professor and head of the Department of Food Science and Technology and Director of the Center for Food Safety and Quality Enhancement at the University of Georgia.  Expertise in microbiology and food science.  This is Mike's first year on the Board.  He also served as a member of the CFSAN Peer Review Panel, the report of which you'll be hearing later on this morning.
		So those are all the Board Members.  Let me introduce the rest of the people around the people briefly.
		Joe Levitt, Director of the Center for Food Safety and Applied Nutrition, and Bob Buchanan, Joe's right hand scientist.  You are the right hand scientist. 
		(Laughter) 
		Dr. Steve Sundlof, Director of the Center for Veterinary Medicine.
		Dan Casciano, the Acting Director of NCTR. 
		Dennis Baker, the Associate Commissioner for Regulatory Affairs.
		And a special introduction; David Lau is a microbiologist, sitting next to Dennis Baker, from our San Francisco lab.  David is shadowing me for the week as part of a development training program.  So it's an opportunity for him to learn how I execute "Plan B."
		(Laughter) 
		The agenda shows at this point Dr. Henney gives her opening comments. 
Introductory Remarks of Dr. Jane Henney, Commissioner of Food and Drugs
		DR. SCHWETZ:  Fortunately, I have a copy of what she was going to say, but I would also tell you that they are just bullets, so the intervening comments are mine.  This is not a prepared text.  Let me assure you that Dr. Henney would have extended heartfelt welcome and thanks to all of you for being here at this Science Board meeting, and particularly those who are new to the Board for your willingness to serve on the Board.  She was instrumental in helping to repopulate the Board.
		The goal for the Science Board; in the selection of new candidates we had a fair amount of turnover; we brought seven new people onto the Board, and the direction that we're taking the Board is slightly different than what we've had in the past when the members were selected based on their expertise and their background, their positions in the community, in the scientific community.  But it wasn't specifically selected on the basis of representing the activities of the Centers of the agency.
		At this point Board Members are being selected because you have expertise that is specific to part of the agency, and that we have board representation that covers the range of the agency; and as a result, the repopulation of the Science Board has tried to accomplish that.
		One of the goals that we have in the future is that the Science Board would play an even stronger role in peer review of the science of the agency.  So we want Board Members to represent the range of science of the agency.
		The intent is that we would have a Science Advisory Board within each of the Centers, and the Office of Regulatory Affairs; and that the person who would be on the Science Board would in some way be affiliated with the Science Advisory Board within one of the centers.  You might be a member of it, you might be the chair of it; because we don't have science advisory boards in all the centers right now, that is not how we're going to operate this year.  But eventually we'd like to move into that position, so that every center has a review board and that the Science Board consists of the representatives from those Center and ORA boards.
		What we are looking for is that the science board would be advisory to the highest level of FDA management on broad scientific issues of the agency, and consistent with Dr. Henney's efforts to strengthen and rebuild the science base of the agency, that you would have advice on how that process continues to move forward as we try to enhance that science base.
		There are some changes that have taken place since the last Science Board meeting, which was before Dr. Henney came in as Commissioner.  One of them is that Dr. Elkan Blout, who was a prominent part of all of our Science Board activities in the past, is no longer an expert adviser within the FDA.  Elkan has continued to go on his path and is no longer an advisor to the agency, and to the Commissioner.
		Instead, I have taken over as that senior science adviser to the Commissioner and to the agency, and Dr. Henney also asked if I would serve as the Acting Deputy Commissioner while the search goes on for a new Deputy Commissioner.  So I've got two hats, as I often have in the past; and one of them will come off when we bring in a new deputy commissioner.  So I will continue to serve as the Senior Adviser for Science in our Office of Science.
		Dr. Henney has asked, as expected, that when the new commissioner comes in, the new commissioner will be someone with a strong science background, and between myself as the chief scientist and the deputy commissioner with a strong science background, the two of us will represent the science front in the Office of the Commissioner for the agency.  And she intentionally wanted that so that it gives a strong message of science next to the commissioner, in her office.
		Dr. Henney's priorities continue to be, as I've mentioned, to strengthen the science base; and that has a lot of dimensions to it that we've been working on; everything from training of our people and retraining of people so that we have the expertise that we need to do the work that's in front of us; but stronger efforts towards recruitment when we have the opportunity to hire people to be sure that we're getting the best people that we can; and efforts to retain the good people that we do have, the people who are doing the job that we need to have done.  We tend to have turnover, as every organization does, and it often is people whom we would like to retain.
		So we're trying to develop better programs to retain our scientists.  So beyond retraining and training and recruitment and retention, there are always issues of facilities and equipment and systems that it takes to do the work; those are all parts of the priorities that the Commissioner has for strengthening the science base of the agency.
		As we have built the budgets in the last year and next year, and as we look into these next few years, there are a number of things that are prominent in the agency that clearly are scientific issues that become part of our budget building process.  Those kinds of things are what we consider the ‑‑ we give attention to the highest priority risks that we consider are related to the areas that we regulate; and examples I would give you are in the area of medical errors, drugs over the Internet and dietary supplements, what we're doing with clinical studies and IRBs, the interaction that we have there with the products that we regulate.  
		Blood safety ‑‑ these are all things that have been high priorities of the Commissioner since she came in a year and a half ago; they continue to be priorities, but as things like the medical errors and the Internet sales of drugs, new things come up, the emphasis changes, but there aren't any of the priorities that Dr. Henney promised when she was approved in Congress; there aren't any of those that are not a priority anymore.
		One of the things that we continue to put more emphasis on within the agency is leveraging, and more efforts to collaborate with people who can help us.  In efforts not only to expand our capacity to do work by leveraging and collaborating through the physical capabilities that colleagues represent in the academic setting or industry, or in other government agencies; but also the opportunity that it represents for us to reach out and get intellectual capacity that we don't have in the agency; and the technology is changing faster now than it has at any time that I remember; and the ability of a federal agency to respond quickly to changing technology is slow when you do it by the process of hiring and training.
		So to the extent that we can leverage our resources and reach out where the expertise is already available, and through one way or another bring that expertise to us to benefit the decisions that we need to make, it's a quicker way for us to respond to the changing technology than through a hiring process.  But we can't do it all through leveraging, either; we have to hire people, and you'll be hearing some more about that later on this afternoon.
		We have some examples that we consider to be quite successful leveraging activities, and developing the interface between us and the regulated community and the academic community.  One of those is a Product Quality Research Institute that's been formed that has to do with the pharmaceutical pooling resources to work on questions that relate to product quality and GMPs.  This is work that needs to be done to provide guidance on inspections and GMP activities.  
		These are studies that can be done through the money that's provided in this foundation from industry; the FDA is involved in it from the standpoint of setting priorities of the work that would be done, and then when the results are generated, this information will be used by industry and by the agency to decide questions that relate to product quality; for example changes in manufacturing that might change the quality of a product.
		What kind of data do you need to assure that this change in the manufacturing process doesn't change the product?  It's that kind of an effort.  So the PQRI is one example where we've been leveraging to get work done that otherwise wouldn't have gotten done, that we would have been conservative and said "Well, you need this and you need that and you need that," when in fact doing a little research defines what you need.
		Another one is the Moffett Center in Chicago, an effort that CFSAN has been involved in for a number of years, and it is a place where the food processing industry can come in and work hand-in-hand with FDA researchers dealing with some of the issues that, for example ‑‑ and Joe, you can expand on this if you want to ‑‑ but pasteurization techniques, and other things that have to do with problems that we're having with foods today; research can be going on there with industry and the FDA to try to understand how to improve the safety of food.  So it's another leveraging activity in a place where we can work side-by-side with industry and academic colleagues to get work done that otherwise wouldn't have gotten done.
		One of the things that the Commissioner was going to mention is a survey that was recently released in a draft form.  It isn't out yet in a final form, from the University of California-San Diego, it's a group that has been doing a survey on the performance of the FDA every two years for the last six years.
		There is interesting information in that survey, because they've gone out to hundreds of companies that we regulate to get information -- this is primarily the pharmaceutical and the device industry ‑‑ and ask them just simply how the FDA is doing in terms of its performance in interacting with the industry that we regulate.
		Because this has now gone on for several different survey periods at two year intervals we're beginning to be able to see trends.  And it becomes even more valuable to us than it was just the first time or two; and some of the kinds of things that have come out of this suggest that there is an improvement in the communication between the FDA reviewers and the sponsors in terms of the value of presubmission meetings, the ability to get ahold of a reviewer, the length of time it takes to get back, the quality of the guidance that is provided to the industry when more studies are asked for; is it clear what's asked for?  Is there a clear definition of what it would take to resolve the question that might have been under discussion.
		So there have been a number of improvements, but there are also a couple of problems that were identified that are not new to us; and they are ones that we're working on; and one of the things that we'll talk about this afternoon is, we talk about personnel matters.  But for example, one of the difficulties is personnel turnover.
		You have a reviewer who's been working on a submission for a period of months, and that person gets either moved to another project, or what has happened quite a few times is the person gets hired by industry.  So that's a double-edged sword.  It slows down the process when a submission goes to another reviewer; but part of the cause of that is the people who are doing the reviews are being hired by the companies for whom the reviews are being done.
		So we have this problem of turnover of people, and that's something that we're going to be working on to see if that can be made more smooth than it has been before.
		There still is room for progress on presubmission meetings between the FDA and the companies, and that's something that we will continue to work on. 
		So the survey has given us that kind of guidance, and it helps us to confirm what our priorities should be as we work on trying to improve our performance.
		Well, how can the Science Board be of specific help to us?  The broad statement would be that you can help us to assure the high quality of science at the agency; that would be a general expectation that we would have.  There are more specific things, of course.  One of them is that we would like the Board to be more actively engaged in the peer review process of the science of the agency.  
		We have undergone a review under the direction of the science board of the Center for Biologics, and more recently the Center for Food Safety and Applied Nutrition.  We're going to continue to move through the other centers in doing these peer reviews, but we want the Board to be more actively engaged in peer review than it had been before we started this center-by-center review.
		So that's one of the things that we want to get from the Board; is advice on how peer reviews should be done, from your experience.  But probably more importantly, as we learn more from these peer reviews, how to improve the science of the centers on the basis of what we learn from the peer reviews.
		We would like to have your advice as we go forward on retention of employees and recruitment of employees, the scientists of the agency, and to get your input on how we can best do that from ‑‑ you represent a range of experience, and we would like to learn.  We will be telling you this afternoon, in the case of Alan Rulis, of an example where we have an opportunity to hire about 50 people, and it's uncommon in this agency today that you get to hire very much people except for the areas that are supported by user fees where we have hired up; but it isn't very often that we get an opportunity to hire a block of 50 scientists at that time.
		I've asked Alan Rulis to bring his plan to you, at an early stage, to lay out how they're going to make that entire activity, make it work.  What I'd like to do then is bring it back to the Board in six months or a year, whatever, to look at the progress that is being made when we are hiring this significant block of people, and get your advice on how it could have been done better or just in general whether we got the right scientists, if we got the best ones that we could; so that's another area that we would like your help on.
		I've already mentioned the need for us to retain the flexibility that it takes to respond to new issues and new technology.  And again you coming from organizations where flexibility is important, we would benefit from your advice and comments on how to build flexibility into our workforce so that we're able to respond and anticipate what kinds of science backgrounds we need in the agency to be able to deal with the issues.
		In addition, one of the things that we would hope that Science Board members would also do is to serve as ambassadors for the FDA; that as you learn more about the agency and what our issues are, that as you have the opportunity to clarify in public or in your organizations ‑‑ Mike, join us at the table, please.  This is Mike Doyle.  Mike, glad you could be here.  
		That you would serve as someone who can clarify what the agency is about, and that you are involved in the science and we would just ask that you would speak up as you see fit for the agency.
		So those are some of the things that -- and I haven't followed Dr. Henney's bullets point-by-point exactly, but that's the general ‑‑ Mike, I explained that Dr. Henney is sick today, and we just learned that a little bit this morning, a little bit ago.  So I am just giving opening comments on her behalf.
		With that, I would open it up for any discussion or questions or ‑‑ before we move on to the rest of the program. 
		Let me explain also, one of the functions of "the shadow" is that any questions today that I can't answer automatically go to David. 
		(Laughter) 
		I didn't tell you that earlier, David.  But please stay for the meeting.
		Any comments or questions before we start?
		Then Bob, I'll turn it over to you.
		DR. LANGER:  The first presentation will be by Dr. Fennema, which will discuss the Science Board report on the Center for Food Safety and Applied Nutrition.  So I'll just turn it over to you.
Science Board Report on the Review of Research at Center for Food Safety and Applied Nutrition 		[Dual screen displays]
		DR. FENNEMA:  I thank you, Mr. Chairman, and it is a pleasure to present to you the results of this review, which was in fact itself a pleasure to do, because of the cooperation of all parties.  So I have a few transparencies to take you through here, which will kind of give you the essence of what happened and what some of our recommendations were.
		[Interruption; fixing audio] 
		[Overhead]
		DR. FENNEMA:  This first slide that you see here is simply kind of the nuts and bolts of how the committee was put together and when it took place.  It was done of course under the authority of this Board here, and it took place in April of last year in the Cohen Building in Downtown Washington, D.C.
		The emphasis of the review was on the research activities of CFSAN, and the objectives were to improve the operating procedures and management practices of CFSAN so that it can continually and easily update its priorities in accordance with needs, and accomplish its mission-related tasks more rapidly, efficiently and effectively.
		So the committee consists of 22 members; all of you at least on the Science Board have the full copy, and in the Appendix One are listed the 22 members that took part in this review.  
		The nominations for service on this review committee came from the Science Board and from CFSAN itself; and I contributed to it myself, and these were discussed and a committee was ultimately picked in that manner.
		The procedure went as follows:  CFSAN provided the review committee with relevant documents in advance of the meeting, and this was quite a large stack of material, as you might imagine, this committee had to review.
		Then during the course of the review, there were basically six presentations made by CFSAN personnel, and each of these presentations was followed by rather extensive discussion.
		And throughout the course of the several days, there was discussion between the CFSAN senior management and the review committee, covering issues which were best dealt with in that particular fashion; and then at the conclusion of the review, the committee met in isolation, had a whole battery of computers at their disposal, and there were six subcommittee chairs, and these subcommittees got together and drafted the rough drafts of their recommendations.  These then were all given to me, and I went back and put those together as best I could, and consulted with the sub chairs, and the report was finally put together.
		So the next phase. 
		[Overhead]
		So these are some general aspects of the results of the review; and this now refers to CFSAN, the research quality is considered generally good and no doubt, no surprise, that there is some variation in the quality of research among groups.  All the research groups are doing appropriate kinds of things.  The types of activities and level of support in the committee judged barely adequate to accomplish CFSAN's mission.  That again came as no surprise to anyone.
		There is a recommendation that CFSAN must maintain mission-related research programs of world-class quality, and of a size commensurate with its mission.  That, in the committee judgment, is a very, very important principle that should be kept in mind constantly; and all those who are involved with budgets should be aware of that.
		For balance, the programs in toxicology and applied nutrition need to be strengthened; in the response that will come right after this, you'll see some efforts being made in that particular regard.  And in personnel, make greater use of postdoctoral and student personnel; increase the number of support personnel for scientists.  That is a deficiency which occurs in many, many organizations; industrial organizations, universities as well as government.  There's a lot of chiefs and not enough Indians, and that's certainly true within FDA that that prevails.
		Improve the performance review procedures.  It was our impression, on the review committee, that these procedures being used to review the performance of FDA personnel needed to be upgraded and improved, and I think that can be fairly easily done.
		Strengthen professional development programs.  And the next, please?
		[Overhead] 
		In terms of management, a strategic plan should be developed soon.  That is in the process of being done; I believe you'll hear something about that in the response.
		All personnel should be fully cognizant of the goals of their programs, and each project should be reviewed annually.  Thirdly, CFSAN should budget on the basis of programs rather than FTEs, full-time equivalents; which is easy to say and may be difficult to do, but it would be a good approach to be taken.
		The Science Board and CFSAN management should consider this review the first of three steps.  Step 2 should occur six to nine months after Step 1 and should consist of a review of progress toward developing a sound management strategic plan; Step 3 should occur 12 to 18 months after Step 1 and should consist of an evaluation of how well CFSAN research activities correspond to the strategic plan.
		None of that is happening as far as I know, but that was something that the review committee considered desirable.
		[Overhead]
		Some other matters:  Research activities at FDA field laboratories should be carefully assessed as to appropriateness.  We had a little uneasiness about this, and whether this money being spent on research activities at field laboratories was the best way to expend research funds.  We recognized that some of this is indeed appropriate, but we weren't convinced that all of it was.
		Emergency response procedures appear to be effective, but care should be taken to assure that these procedures do not disrupt unduly the work of ongoing programs.  This is a difficult task to do.  When an emergency comes upon the agency, they take personnel from wherever it is needed to respond to the emergency, and this does have the effect of interrupting the progress of other programs within the agency; and this is something that needs to be looked at carefully, in the committee's judgment.
		Purchases of instruments should be carefully prioritized; you'll hear something about that in the response as well.  Certification of laboratories should be accomplished in all instances where this is critical to accomplishment of the CFSAN mission, particularly in regulatory issues this is a point of critical importance.
		Research on cosmetics should be closely coordinated with other dermatology, transdermal research being conducted by FDA.  And participation of CFSAN personnel in CODEX and other similar international programs should continue.
		This is an important point, in the committee's judgment, that FDA personnel be kind of involved in a matrix, and the interaction with industry and other governmental agencies across the world in all of these kinds of activities. 
		The FDA should in fact be a leader in these kinds of activities, and this is, I think and the committee thinks imperative.  One of the features that is imperative to maintaining a comfortable, rewarding atmosphere for personnel within FDA.  It's not that they get stuck in their little hole in Washington, D.C., but they're allowed to get out and interact with their peers in other groups and agencies.  This is a stimulating sort of experience, and very, very important in the committee's judgment.
		CFSAN should assure that information on relevant new technologies is transferred effectively to the food industry.  Again, you'll hear some response to that in a moment.
		Next, please.
		[Overhead]
		There are six individual programs that FDA is organized in in terms of CFSAN activities, research activities; and just a few comments about each one of those.  The antimicrobial resistance and tolerance, research in this area is important, it should be carefully integrated with work in other centers of FDA and with other governmental agencies.
		Hazard assessment, chemical risk, this is an important area and work should be coordinated with other centers in FDA.  This is one of the best ways to make best use of personnel, is this cooperative procedure which the committee has alluded to here.
		Microbial risk, FDA should be a world leader in this area and continue partnership with CDCP; results should be used to improve asept protocols, and in cooperation with other agencies develop a public health-oriented approach to establishing regulatory priorities encompassing the full food chain.
		All right.  Then the Methods Development Group, FDA should develop in cooperation with other relevant government agencies a plan for methods development that encompasses all aspects of food safety.  Duplication of activities in academia and industry should be avoided.  Again, this should be done in cooperation rather than competitively with these other groups.
		Next, please. 
		[Overhead]
		The prevention and intervention program, CFSAN should continue to determine, in cooperation with other groups, safe practices for new or modified food processes.  Secondly, CFSAN should be a world leader in establishing standards and procedures for assuring the safety of food crossing international boundaries.
		Like it or not, FDA is in a role where that is absolutely essential that that be done.
		Regulatory testing analysis and color certification, the regulatory testing, the current practice of operating all laboratories under a good laboratory practices quality assurance program and maintaining certification of those laboratories conducting analyses for regulatory purposes is strongly endorsed.  This, in the committee's view, is absolutely essential.
		Color certification, new methods and instruments should be continue to be evaluated and put into use to enhance service to clients and to maintain appropriate skills with CFSAN.
		And applied nutrition, foods and food labeling, a strategic plan is needed; program collaboration with appropriate groups in and outside government should be pursued, and areas of special importance include dietary supplements, natural products, nutri-suitables
and allergens.
		Next, please.
		[Overhead] 
		This is something that struck me rather strongly, and I think many members of the committee as well, that there were some shortcomings in the review.  This has nothing to do with lack of cooperation, because the cooperation with all members of CFSAN was indeed excellent; they did everything in the way of cooperation that anyone could expect them to do.  But there are some ways the review procedure can be improved.
		So there don't appear to be any standard procedures for the conduct of FDA reviews.  This to me is a serious shortcoming, and the committee feels that way; that this is something that we should have a document of some kind ‑‑ it doesn't have to be very long; several pages will do ‑‑ describing to the units which are to be reviewed what is expected of them in advance.
		And CFSAN's intentions were indeed sincere, as I mentioned; but a lack of instructions well in advance of the review lessened the value of the review.  And particularly important was that the process of self-evaluation which, in my judgment and in the opinions of many on the committee, is absolutely crucial to a good review, was not conducted.
		Review committees like to hear what the group being reviewed feels are weaknesses, strengths, where areas can be improved; and we heard very little of that.  Some of that we eventually were able to gain from the leaders in CFSAN through private consultations, but this is something that should take a fair amount of time within the group being reviewed to conduct this self-evaluation and to write a document which deals with self-evaluation.
		The results of the review would be immensely better if this were done; and that's one of the aspects, in the committee's judgment, should be built into these guidelines for reviews.
		So the recommendation here is ‑‑ and this doesn't deal with CFSAN; this deals with this Board right here, that the FDA Science Board should prepare guidelines on how to prepare a review.  And further FDA review should not be conducted until these guidelines are in place.  And I think that would greatly enhance the value of them.
		So thank you.  If there are any questions at this point, I would be happy to try to answer them.
		DR. LANGER:  Any questions at this point?  Or would people like to go on to hear the response, and then ask questions.
		DR. DAVIS:  Just one question, as a new member.  How long did the review take?
		DR. FENNEMA:  Three days, I believe it was.  Is that right, Mike?  Yes.
		DR. LANGER:  Other questions? 
		[No response.] 
		Then maybe we'll go on to the response, and then maybe we'll have more questions.
	FDA Response
		MR. LEVITT:  Thank you.  Dr. Buchanan is going to give our detailed response.  I want to just give a few minutes to kind of set the stage for him.   
		First of all, I want to thank Dr. Fennema and other members of the review panel, several of which are sitting here in front of us today; Dr. Nestle, Dr. Doyle.  We found this process very, very helpful to us.  I really want to thank you both for the time, the commitment and the level of expertise and energy that was brought to the process.  And Dr. Buchanan will lay out a number of things, what they're trying to do is helping us with our planning, with our budgeting, and across the board.
		And I, too, am sorry Dr. Henney is not here today.  But I can assure you, I have worked at FDA for over 20 years, and there is no commissioner I've worked with that has highlighted more the importance of science undergirding all these activities than Dr. Henney is.  So I'm sure she must be pretty sick, to keep her away from this meeting today.
		For those of you who don't know me, I'm not a scientist; I'm a lawyer, and when I took this job a couple years ago, it was very clear to me that I needed to be sure if I was operating effectively in the job.  I needed to surround myself with strong scientists.
		So one of my first appointments was Dr. Bob Buchanan, who is a microbiologist, has a background in a number of areas; worked at U.S.D.A. as well as at FDA, and he headed up our review team.  He did not do it by himself; there are others, and I'll mention those in a minute.
		I also want to introduce to the group Dr. Susan Alpert, who has recently joined us.
		Susan, if you'll stand up in the back ‑‑ who is our Director of Food Safety.  Susan is a pediatrician with a background in infectious disease as well as a microbiologist who worked most recently in the Center for Devices and Radiological Health; their loss is our gain.  And already, in just a few months, she's having a major positive impact on our program.
		We also have, in addition, about a half a dozen scientists that have met the criteria for SBRS, the Senior Biomedical Research Service.  And a number of them are here.  Sam Page, who is our scientific director of JIFSAN ‑‑ if you could stand up, Sam.  Sam has worked in the center for many years, has expertise in chemistry and a lot of other areas; and a wealth of knowledge and information, and is one of the key people that helped put together our review team.
		I also see Tom Sabulla, expert in molecular biology, and again is one of our ‑‑ when somebody was talking about world-class scientists, Tom Sabulla is one of the people they were talking about in the antimicrobial resistance area.
		In terms of new hires, I see Bob Bracket here, who has recently joined us, from a place that Michael Doyle knows well, in microbiology; and again, just a very short time.  We're delighted that this is the kind of people that we are able to attract into our program.
		Not with us here today, but Bob will mention that we have recently elevated Dr. Beth Yetli (ph) to the role of what we call lead scientist in nutrition, as a way to help bolster and provide more leadership in that area.  We also had two recruits over the last couple of years; Arthur Miller and Richard Weiding (ph) that Bob Buchanan both helped recruit from U.S.D.A.  Art Miller is serving as our lead scientist on the Food Safety Initiative, Richard Weiding on Risk Assessment ‑‑ and would be here, but he is locked in a closet working on our Listeria risk assessment ‑‑ in terms of trying to bring that to closure.
		We also have worked hard and will continue to continue our collaborations with other parts of FDA, especially with Steve Sundlof, his group at CVM; Dan Casciano at NCTR, and Dennis Baker in ORA.  
		I like to joke that ‑‑ I feel I can because I've worked in all parts of FDA ‑‑ that FDA kind of has the medical half and the edible half; and we're kind of representing the edible half of the FDA.
		But I think especially through the Food Safety Initiative we fund a lot of additional collaborations.  In particular, Dennis Baker and I have embarked on a pretty substantial effort.  The field has about 50 percent of its resources devoted to the foods program.  We are actually the only part of FDA that has a larger component in the field than we have at headquarters.
		So we have embarked on a major, if you will, team building and collaboration effort across all of our major program areas, and one of the areas is laboratory management.  And some of the comments that Dr. Fennema mentioned will be undertaken within that auspices.  We have the good fortune of having some new laboratories in Arkansas and in New York; so as we start to redesign the laboratories, we can build in some of today's needs that we have.
		And finally, we're working on strengthening our efforts with other federal agencies and state agencies as well; particularly CDC, U.S.D.A., EPA, increasing work with NIH and the area of dietary supplements that I'll speak to a little later on.  
		As well as really across the country in the state departments of health and departments of agriculture also.  So we feel that this is a program that is trying to build very strongly on a foundation of science; we have benefited over the last couple of years the increased resources.  Those resources on one hand have been earmarked.  On the other hand they have been earmarked in some important areas; and that has helped us kind of turn the corner.  
		We had about 20 years of pretty close downward trend; we've had a 20 percent reduction over 20 years in the personnel in our program, the only program in FDA that has had downward as opposed to an upward trend over that period.  And the Food Safety Initiative has given us a real booster shot to turn that around.
		And we recently also received the resources for our food additive review process.  We'll be able to strengthen expertise in toxicology and chemistry and other areas.  So we feel we're on the upturn.  I think that this report came at the perfect time for us to use and build in that building process.  
		And with that short introduction ‑‑ I hope it was short ‑‑ I'll ask Bob Buchanan to give a more detailed review.
		DR. BUCHANAN:  Thank you, Joe.
		[Overhead]
		First I'd like to start off by thanking Owen and Marion and Mike and the rest of the team.  There was a question that came up, how many days did this review take place, and by the calendar, it was three.  By number of hours per day, it was about eight.
		They were very long days; they started very early in the morning and they lasted very late at night.  And when they weren't actively seeking information, they were holed up with their dozen computers, and everyone seemed to be very computer literate, certainly on the team.  I walked in at one point and they were all typing away.
		We want to thank our team; they did a marvelous job.  I'd also like to focus a little bit on our responses.
		As you can see from the dates on the report, there has been, because of the Science Board's ‑‑ a substantial lapse; so I'd like to focus not so much on the report and commenting specifically on the specifics of it in terms of "yes or no we don't agree," to "almost everything that's in the report, we agree."
		What we'd like to take the time to do is to take and tell you what we've done in the intervening year to actually deal with some of the issues, and also talk about some of our plans to deal with additional issues that we haven't had time to get to yet.
		[Overhead]
		I'd like to just briefly talk on the three points here on the overall evaluation, and then I'll come back to some more specifics that were raised on what we've done.
		As the review team quickly found out, that we had almost two systems of research when they reviewed us, or research management.  One associated with the Food Safety Initiative that had very strict accountability requirements with the funds that came in with it, as opposed to the sort of less accountable nature of the research activities that had taken place before.
		This has been changing during the past year as a result of two things, and I'll get to more details also later in my commentary.  One is that during the past year, there is a broadening of the Food Safety Initiative to include a much wider range of activities.
		So, for example, there is now an inclusion of pesticides, natural toxins, et cetera, items that hadn't previously been under the mandate.  So we see the Food Safety Initiative embracing those areas and also we have the capability of devoting some of the funds that came in with the Food Safety Initiative to those areas.
		We've also used the Food Safety Initiative to experiment on how we can better manage our scientific resources.  And the lessons that we've learned during the past two years with this approach, we're taking those lessons and now broadening them to our entire research activities, center-wide.
		We have done some very specific things in trying to help this coordination and increase both our planning process and our accountability.
		Joe already mentioned that I was appointed the Senior Science Advisor and head of the CFSAN Office of Science, whose function is to focus and coordinate our planning activities, our active use of our resources, and also help provide a review function.
		We've also, to help in this process, formed the CFSAN Science Council, which is a multidisciplinary council of our senior scientists that meet approximately monthly to discuss issues that have come up of a scientific nature.  I was also very pleased to hear Bern mentioning that we can now rely on the Science Board and get you involved in our activity through our Senior Science Council; so I'm certainly looking forward to involving Owen and Marion and Mike in some of our activities, as much as I know your busy schedules will allow it.
		[Overhead]
		Let's talk about a couple of specifics.  Two areas in terms of broad program that were identified as needing strengthening or certainly recommendations that we strengthen were in the areas of toxicology and also in the areas of nutrition.
		I want to link these together, because they actively are linked together in our program.  Talk about a couple of things that have taken place during the past year.  One is in the area of recruitments; we have been given permission and have started the recruitment process for two senior level scientists that we think will be key to the area of recruitment.  One of them will be an SBRS level toxicologist that we are going to be starting a national recruitment on shortly.
		The second has to do with one of our facilities; and we have just completed a yearlong review of our activities at our primary site for doing toxicological research within JIFSAN; this is our facility that is known as Mod 1.
		Now we've taken a complete look at Mod 1, how we conduct business out there or what kind of research is taking place, and it's helped focus our activities in terms of our toxicological capabilities, both in terms of the personnel, the services that they provide, the research that they do, and the infrastructure and the organizational needs that are associated with that.
		The draft report has been just submitted, and one of the recommendations of that draft report which will be finalized shortly is the establishment of a program office at Mod 1.  Which would include again the recruitment of an SBRS director that will be responsible for both the program and the administrative aspects of that facility.
		We feel that that will have a tremendous impact on having a champion to help focus our toxicological work.
		I'd like to also mention collaborations.  We've spent a great deal of time during the past year trying to establish increased collaboration and leveraging both within FDA and also with some of our both formal consortia and with the scientific community.
		I'd like to first highlight the fact that we continue to work closely with JIFSAN, our Joint Institute for Food Safety and Applied Nutrition here in conjunction with the University of Maryland; and we've seen a substantial increase in the collaborative projects with this organization.
		We've also built bridges to Arkansas, and we continue to try and enhance that; in fact, we just had a team that came back ‑‑ I guess they were down last Friday.
		Looking into the next area, and if I can have the next slide.
		[Overhead]
		Is the identified area that we need to target some of our research activities, is it strength our nutrition program?  And we've had several different activities associated with this; and this includes a rather in-depth review of what kinds of research that we're doing in the area of nutrition; and why we will maintain active research activities and a variety of subjects in nutrition.
		I want to indicate that we are going to be doing a high degree of focus in the area of dietary supplements.  We'll be hearing more about our dietary supplement strategic plan from Joe in a few minutes.  But this is, in terms of the agency's need, the most particular need, the most important need in terms of nutrition research now.
		So there will be a focusing of our nutrition research ‑‑ not totally, but certainly in this area ‑‑ and this is intimately tied in with our toxicological program.  Since one of the primary areas we're interested in is going to be in developing methods for the evaluation of the safety of these products.
		Now in conjunction with this, there has been a realignment within the Center in terms of nutrition; there has been a merging of our office of Food Labeling, and our office of Special Nutritionals into a single organizational entity.  
		In this process, we have also elevated Dr. Beth Yetli, one of our SBRS-level scientists; she has been named as lead scientist for nutrition.  She is now part of the Office of Science staff, and one of her key roles is developing the research agenda in the area of nutrition, particularly in the area of dietary supplements.
	[Sound signal failure; 20 seconds lost.
		DR. BUCHANAN:  Again I want to point out that the reevaluation and the total review of the toxicology program is one that has helped also focus our work in dietary supplements.  
	[Sound signal failure; 5 seconds lost.]
		I'd like to believe it's my electrifying personality. 
		(Laughter) 
		MR. LEVITT:  I thought it was [signal loss] a response. 
		(Laughter) 
		DR. BUCHANAN:  That, too. 
		We have also had a high degree of interest in - [signal loss] - focuses of FDA; and that's establishing doing things through leveraging. 
		One that I wanted to highlight here is, we had in-depth discussion on the development of a collaboration between the University of Mississippi's national center ‑‑ [microphone adjustment] 
		Okay, I'll just speak up a little louder and bounce it ‑‑ I'll ricochet it off of here and back to you.
		One that I wanted to highlight is, we've had in-depth discussions in planning for new research activities in conjunction with the University of Mississippi's National Center for Natural Products Research.
		And this will be in the area of a collaboration between [signal loss] CFSAN and the Center for Toxicological Research and the university.  And we're very excited about being able to augment our research capability in dietary supplements through this and other activities including our activities with JIFSAN.
		Can I have the next slide, please.
		[Overhead]
		A couple of issues about Personnel Management, and just some activities that I wanted to highlight.  Again taking the cue for things that appeared in the report in terms of recommendations and things that were actively -- [adjusting microphone] 
		I wanted to mention four, though there are only 3 on the slide; there's one I'll stick in in the middle of it.  One is the recommendation for a postdoctoral program.  We couldn't agree with you more; but actually in setting this up we have just initiated what we call a competitive intramural laboratory support program, where we will be asking our scientists with a certain degree of funds that we have available for this, to put in proposals for either postdocs, support scientists, student interns, a variety of potential supports to help us in our attempt to both keep the science fresh and also provides a means of reducing the ration of principal investigators to support personnel.
		Now this is always a dilemma for us because as we go through and I make please to make sure that we have an appropriate ratio; but we also, our scientists work in the review area, too.  So there's always this balance; do we need a high level scientist to help with the review function or do we need to have additional support personnel. 
		So we're trying to find that delicate balance, and this is one of the tools that we think will help.  
		In terms of this process, we're also going to be relying very heavily on JIFSAN and NCFST, our National Center for Food Safety and Technology, in Summit, Illinois, to provide us with both training opportunities ‑‑ and both of them have an educational component and we're hoping to tap into that more actively.  Probably the one that rises to the surface right now is getting our risk analysis program at JIFSAN started, and this is certainly one of our high priorities at JIFSAN.
		The third item, which does not appear on this, is that I'm very pleased to announce that we will be starting a CFSAN staff college shortly, and hope to have it up and running for the beginning of the new fiscal year.  Joe just gave me permission last night to be able to announce the formation of this staff college.
		The other area that I wanted to point out, again looking for ways to increase the productivity of our scientists, is we have just initiated a review task force that will be going back and looking how we conduct peer reviews of our individual scientists within CFSAN, to identify if there is anything in that process that is acting as a barrier to their advancement. 
		Again, we're looking to get the most from our scientists and make sure that their careers advance throughout their careers.
		Next slide, please.
		[Overhead]
		One of the reasons that we're volunteered to be sort of high on the list of people that went through a program review is that we had an interest and we had an opportunity in time, and we had a perceived need to better manage our research resources.
		We've used your report as the basis for some initiating a variety of activities.  I'd like to just highlight a couple of them, and also talk a little bit about strategic planning.
		As we took the recommendation for strategic planning and read it, we realized that while we were actively doing strategic planning in individual areas, and --
[sound signal loss]
		We've taken to heart the recommendation on equipment purchases.  We now have a center-wide priority setting process for the purchase of equipment, which has been conducted now for two years; first only with FSI, and this past year for all scientific equipment.
		This has had the added benefit of, when we have a priority list and monies become available, we're able to jump in at the last minute and be able to purchase it.  So we've done incredibly well in the acquisition of scientific equipment this past year; including funding major pieces of equipment including two new mass specs.  So I am very pleased with the way this has worked.
		We continue to support and, both in spirit and also in terms of finances, the establishment of the Joint Institute for Food Safety Research.  This is the interagency committee for setting research priorities in food safety, that is working in conjunction with the President's Food Safety Council.  I believe that they're just about to name the new director of this group, after completion of the interviews that took place a few weeks ago.
		Other activities, we note the support in terms of lab accreditation, and in fact this is a cry that has taken place all the way up to the commissioner, and the FDA itself is busily involved in accrediting all of these laboratories that do regulatory samples; and I'm sure that Bern can supply you more details about what's taking place across the entire agency; but certainly we have an active group that is planning first to accredit our color certification program and then the rest of our regulatory samples over the course of the next two years.
		We note your concerns about our ability to transfer technology.  We agree with those concerns, we've put a lot of work into working with our National Center for Food Safety and Technology, as an example of how we've done it successfully.  We're also working with the rest of the agency to find out how we can do this better, faster and more effectively.
		[Overhead]
		Just to make sure that the Board doesn't think that we've ignored some of their individual recommendations in terms of program, I did want to put up two of these.  One, we thank you for the vote of competence in the area of antimicrobial resistance.  Our researchers here are working very closely in conjunction with the other activities in antimicrobial resistance throughout the agency.  We noted some of your concerns in the area of research and tolerances, the development of tolerances by organisms, and we had a review and refocusing of that to primarily support our regulatory needs in the development of standards such as the standards for pasteurization and other processing.
		Methods development, we again note your concerns about the potential for redundancy.  We've again gone back and we continue to look at that.  I might note that we just got very good grades from a GAO report on how we use methods, and our methods development research; they were very supportive of our activities, and we continue to keep these focused in conjunction with our needs to develop official methods and to be able to evaluate them in terms of our needs for different food matrices.
		I do want to point out that we keep an active involvement in not only rapid methods but also more classical methods that are an integral part of our regulatory mission. 
		[Overhead]
		And then I'd like to end this on a note with the recommendation that we get out and work with people that are out in industry.  This is industry and academia, et cetera.  This is one of the key notes of the Commissioner's remarks earlier ‑‑ or our fill-in for the Commissioner.
		Leveraging is a way of life with CFSAN; it always has been, and we continue to try and emphasize that.  Two that I just wanted to highlight that have been activities since the review:  Risk assessment continues to take an increasing important role both as a scientific endeavor and as part of the way we do business in terms of our regulatory mission.
		We have become the world-class organization in microbiological risk assessment, joining that with our being in terms of food chemicals, the premiere agency in the world for that type of activity.  We've made sure that these work in parallel.  Some of the reflection on that is us being actively recruited by both WHO and FAO to help them take microbial risk assessment and apply it on an international level.
		I do want to give, and correct one impression.  Currently I believe there are 18 different CODEX committees, CODEX alimentarious committees.  Of those 18, I believe that FDA has the lead in 14 of them.  A typical committee not only has the delegate, but also has anywhere between 25 and 50 scientists that are working with them, both from industry, from the regulatory agencies, et cetera.
		And while I can't talk about all of the committees, I am the delegate for the Food Hygiene Committee, and I know we've expanded and continue to expand and bring in not just our senior people, but our bench-level scientists to help us deal with the issues that are brought before CODEX.
		So in summing this up, we want to again thank the Board for their review; we thought that it was extremely useful to us and certainly reinforced our own thoughts on how to improve our research and laboratory programs, and look forward to having you come back and help us with some of the details as we go into more depth with individual research programs.
		Thank you.  
		DR. LANGER:  Do you have anything you want to add?
		DR. FENNEMA:  A couple of things.  One, I think the response to the review is excellent.  They considered virtually all the major points in their version of the response to review, so I think that is an element of this process.
		Then I have one specific question; relating back to your written report, which is under the category of personnel management issues, on page 3, you speak here ‑‑ and this is in the area of professional development about which the committee has great concern.  We speak here about the development of a tactical program where you intend to bring in people from universities to spend time at FDA.  What about the reverse of FDA personnel spending some time in industry or universities, short periods of time to upgrade their skills?
		DR. BUCHANAN:  I guess I ‑‑ in trying to respond to a whole range of [sound signal malfunction, 5 seconds]  It's following me around.
		I didn't have a chance to indicate that, where we're going on that.  And I consider this part of our development of a staff college, an active sabbatical program, and getting the resources is something that we have earmarked for enhancing our science-based activities.  
		This has always been a problem of getting the resources, but we've earmarked the resources starting in 2001 to enhance this program.  We'll be setting up a procedure by which our people can apply for the sabbatical.  It will of necessity start small but hopefully will build.
		On the converse, we're actively interested in and have been approached by a number of people within the academic community about taking the opportunity when they do sabbaticals to come in and learn about the regulatory process and being involved in that type of activity; and we're very excited about this potential, and again, this has been earmarked as part of our 2001 activities.  You know, we're always working two years ahead on the budget, but certainly both of those are things that we're interested in.  And will probably be handled under the auspices of the staff college.
		DR. LANGER:  Why don't we open it up for general discussion.  Go ahead.
		DR. ANDERS:  Could you elaborate on CFSAN science council, the composition of it?  How are members selected, rotated, what its objectives are?  And I don't know if you ‑‑ do you have an external scientific advisory board now?
		DR. BUCHANAN:  No, and I believe our external science ‑‑ what I've been hearing from Bern is that we're going to be able to use you to augment our specific people to help us at one of the sounding boards.
		MR. LEVITT:  We are also in the process of restructuring our Foods Advisory Committee to benefit others; Mary Nestle has been on it, and expand that significantly with expertise in particular areas to help assert that function.
		DR. ANDERS:  So then how would your science council interact?
		DR. BUCHANAN:  Our science council right now is primarily an internal sounding board for issues related to the day-by-day operation of science within the center.
		When we've been actively seeking advice on scientific issues outside the agency, we do have a very formal food advisory committee that is set up and structured and has, all official advisory committees within the government, they are very detailed, they have very specific requirements about how we go out and select members.  That is something that we are in the process of finalizing and restructuring, where we're going to take our core advisory committee and then supplement it such that we have a current time for subcommittees that will work in conjunction with the advisory committee.
		Those subcommittees, and I'll see if I can get them right:  One is biotechnology, one is food ingredients and additives, one is food contaminants and natural toxicants, and dietary supplements is the fourth.  So that will be the supplementation and expansion of our advisory committee.
		The senior science council is at this point, and I might note that after a year of operation we're going back and looking at our charter to make sure we have the right mix of people.  But it includes key representatives from the different program offices, their scientific ‑‑ making sure we get representation of the different program needs.  It also includes virtually all of our SBS-level scientists, it includes some key people from different committees, science committees such as our cancer assessment committee; or Mike Bolger for our risk assessment group, chemical risk assessment.
		Now the problem is we've also reached the point where it's a little too large, so we're going back to see if we can streamline a little bit.
		Again, we have the capability of bringing additional people in and out.  The equipment prioritization goes through them; we have certainly the review ‑‑ we just had, next month they're going to be dealing with a proposal for revision of how we approve scientific manuscripts for release; some of the nitty gritty things of how we function.  They will be getting the first presentation of the report on restructuring the management of projects, so that they are our initial sounding boards on reality checks on how we do things.
		DR. LANGER:  [Pointing] One, two, three.  Four.
		MR. LEVITT:  Can I elaborate that with this one point:  One result ‑‑ I've been a center director now for about two years.  One result when I came, which was more a function of time than with me, was that as I referenced before, for literally 20 years this center has had declining resources.  And when there were increased resources, they were for very targeted areas.
		As a result, what happens in the organization, and some of you may have felt the same experience, is when resources keep going less and less and less by attrition, you tend to hunker down and protect what little you have.
		One thing we've done at a number of area science councils, one of them is to try and open that up and create more of a center-wide atmosphere, more of a collaboration across the different offices.  And after the first science council meeting in the center, one of the scientists came up to me and said "Joe, this is the first time we've had that kind of discussion center-wide that I can remember."
		So a lot of it, it's both the tangibles but it's also the intangible of looking at the linkages between the different offices, looking to share equipment, sharing of expertise, and thinking of us as a center-wide program.
		So I would say the intangible is an important aspect of that, too.
		DR. SCHWETZ:  Can we just clarify what SBRS is, because it's been mentioned several times and never explained.
		The Senior Biomedical Research Service is a classification that we're using that is used throughout the Department, DHHS, for those scientists that we considered to be the cream of the crop.  And we have an allocation of 70 of these SBRS slots within the FDA, and half are to be used for employees who already are on board, and the other half for recruitment.
		It's not only a classification scheme that identifies our best scientists in regulatory science, clinical science or research; but it also has a different salary cap.  So it gives us a little more flexibility in the hiring scheme to be able to advertise the position as SBRS. 
		So it's an authority that we use that's a credential service; is has external peer review and internal peer review to be able to get into the queue to even be considered in SBRS.  So it's a system separate from the GS, where you are classifying people up through GS-15 and then SES.  So this is like the SES counterpart for the scientist.
		DR. ROSENBERG:  Once you're in it, are you in it ‑‑ can you also come out of it?
		DR. SCHWETZ:  You can come out of it, because it is reviewed every three years.  And it would be possible to come out of it.
		DR. LANGER:  Bob, and then Ed, and then Harold.  Glad to see we have some questions.  Bob?
		DR. NEREM:  I'm a brand new member of the Board, so I'm still trying to figure out how things knit together; and I'm interested in whether this is the part of FDA that GMOs fits into, for example, under food biotechnology.  So was that part of the review?  Obviously it's an emerging area of public concern, rightly or wrongly, and I'm just wondering ‑‑ I didn't see much mention of it in the report in genetically modified organisms.
		DR. BUCHANAN:  The timing of the review was such that‑‑thank God in some ways--
		(Laughter) 
		‑‑ that issues related to GMOs really hit the fan about three months after this review was completed.  
		DR. NEREM:  So after the review but before the strategic plan.
		DR. BUCHANAN:  Right.  We have certainly had a refocusing of our research thinking in terms of increased interest in GMOs, and in particular how we would be able to assess the safety of them.  We have interests not only here within CFSAN, but I would also indicate that we have interests in the National Center for Toxicological Research, we have interests in the Center for Veterinary Medicine, and we are in the process of developing a three center strategic plan for how we are going to take what research do we have available in this area and make an active research program that will support our regulatory needs.
		MR. LEVITT:  We have also put together a joint proposal in our 2001 budget that is now before Congress.  It's a small amount; it's $1.5 million, but it's at least a start of going this area.
		DR. BUCHANAN:  It just seems to me that this is not only something of relevance today, but also could be viewed as an example of the kind of thing that happens every three to four years, and you can use it as a way of structuring your thinking, how you're going to deal with the next converging issue.
		MR. LEVITT:  I agree; it's both an example of what happens when you have a lot of attrition and it's hard to keep your critical masses; but it's also, when you have an opportunity to take that investment.  As an example, about ten years ago when the Moffett Center in Chicago ‑‑ this has been referred to several times here, both by calling it the Moffett Center which is the informal name, and the formal name is the National Center for Food Safety and Technology.
		In Chicago, when that was developed by now a little more than ten years ago, with the Illinois Institute of Technology and industry.  I can remember when I was in the Commissioner's office at the time, it was viewed as if you will a nice thing, but it was food processing and who really cared much about food processing?  It was described to me at the time as putting a lid on the jar.  And ten years later, all of a sudden it's not putting the lid on the jar, it's keeping the bacteria out ‑‑ well, you put a lid on the jar and it's become really the centerpiece of our Food Safety Initiative research.
		It also has expertise in the area of biotechnology, but it shows the importance of making good investments in scientific capabilities, so they're there when you need them; because if you need them all of a sudden you can't create them like that, as you all know, both for infrastructure reasons and for budgetary reasons.
		What we're trying to do is to kind of program-by-program build that investment across the center, and that's an excellent example of that.
		DR. LANGER:  Ed?
		DR. SCOLNICK:  As I understood the purview of this Board, it was to help in some way oversee the scientific upgrade of the agency that seems to be going on in general in the areas we're hearing today.
		The things that would help me in assessing that, because hearing processes are interesting, but there's not enough substance in that to be able to judge on improving the quality.
		There are three areas that I thought about.  One is, you talked about the recruitments that you're going to do and that you show the Board the results of those recruitments, or you would update us in some way.  I really like to see ‑‑ I know what I would like to see is c.v.s of the people you've recruited and records of the process of letters of recommendation, and who these people were that you've recruited, and you're kept regularly updated on that as one way of assessing the quality.
		The second thing is, I'd really like to see some regular record of what publications come out of the staff of your organization, because that's a coin of the realm if you're going to really upgrade the science of the place.
		Third is, one of the things that I've found useful over the years is to try to boil down what your most important findings are ‑‑ and not a long report.  But if you ask someone about someone, I generally ask them, what has that person discovered?  What have they actually done in two sentences in their life in science?
		That would be very useful to hear about; what have you found in your research internally?  Kind of the three or four most important things, every six months ‑‑ not the whole litany of projects and things, but what are the most important things you've actually discovered that you would put forward as your critical new findings or creative new findings, new technology findings, whatever.
		Those are kind of the areas that, if I'm going to do my job on the Board, I'd like to hear about.
		MR. LEVITT:  I think we'd be happy to do that.
		DR. LANGER:  I think that's an excellent point.  We might want to come back to that point again at the very end; you know, when we talk about future meetings.  That's a very good suggestion.
		Harold?
		DR. DAVIS:  Point of clarification.  One, the toxicology part that you had addressed.  Bern has now defined what the SBRS program is.  I think if you clarify that, that person would fit the bill as an SBRS, perhaps. 
		Second, the SPS level was also mentioned, I think if I got the acronym right, SPS?
		MR. LEVITT:  SES, senior executive service.
		DR. DAVIS:  SES I know, but ‑‑ I'm sorry, SPS.  Somebody said SPS.  So you meant SES.
		MR. LEVITT:  The SBRS, four letters, is for the senior research scientists.  SES, senior executive service --
		DR. DAVIS:  That one I know.
		MR. LEVITT:  ‑‑ I'm an SES.
		DR. DAVIS:  Okay, I thought you said SPS.
		MR. LEVITT:  No.  I must have been talking too fast.
		DR. LANGER:  Yes?
		DR. ROSENBERG:  I'd like to just follow up on Ed Scolnick's comments.  He mentioned three things that he'd like to see measured.  I'd like to just talk about measurements in general; perhaps maybe from your own point of view, as to other measures that you may have thought of or are putting in place so that one can monitor the progress of again some of the recommendations that are coming out, in terms of actually being able to quantitate things.  We talk about quantitations of c.v.s or publications; are there other things that are unique again to your agency, unique to your programs, that we should be monitoring that you feel need to be quantitated.  I'd like to hear that as a Board member.
		DR. BUCHANAN:  Let me answer it in two steps, and explain a little bit about the focus of the process we went through in the review, and then talk a little bit about some of the things that we're looking at as a result of that.
		The focus of the review, we refer it to it as the strategic review, because what we were asking were just some of those questions.  We were looking for not at this point so much a detailed examination of each of our research programs so that was part of it, but we were looking at a Gestalt of the entire program in terms of what are the procedures that would help us optimize our resources.  What are the measurements that would be most useful to measure our productivity?
		Now certainly we do and will continue to rely on measurements such as publications.  But we also need to look at activities such as the completion of risk assessments, the use of the scientific expertise within the center to solve problems and actually provide us with the information that we need to develop new standards to deal with issues that we're facing in terms of the review of submissions or petitions.
		Each of those are activities that we're attempting to get an active objective measure on.  So for example we had the need to generate research related to a question that is facing us in the development of a new regulation or the safety of juice products.
		This activity was completed, it was put forward to an advisory committee -- a different advisory committee ‑‑ and served as the basis for subsequent discussion that I know Mike Doyle was part of, because he's a member of that advisory committee.
		Those are things that we're also trying to figure out how to capture and not limit it to just simply a ticking off of the manuscript as it is completed.
		So again, we certainly think that that's important, and we can provide that to you on a ‑‑
		DR. SCOLNICK:  Yes, but I think the kind of thing that would be useful in that regard ‑‑ if you're doing research in an area to develop new standards for new understanding of food toxicology or food safety, what have you done, what has the outside world done in terms of what progress has been made by any one in the world in that regard, and what have you done to contribute to that.
		It would be very useful for fields that I don't know anything about.  Because you have to put your own work into perspective in the whole science world, toxicology in order to know how effective you're really being. 
		MR. LEVITT:  One nice aspect of the Chicago facility, by bringing together FDA, government, academia, industry is an opportunity to pool resources, especially where the private sector doesn't have the capability.  I don't want to keep giving the example of sprouts, but it's a good example where an industry that does not have the R&D of a major pharmaceutical company by any extreme, doesn't have the R&D of a tiny pharmaceutical company by any extreme, really did not have the resources.
		By pooling together and by coming into a joint facility, we were able to put together a task force and validate; this works, this doesn't work, this works, this doesn't work ‑‑ sometimes the "this doesn't work" is as important as "this works" if that was a tool that industry was using to prove the safety of the product, and we put out guidelines like last fall that were the next increments, based on validation data.
		So there are some important stories to tell.  And I agree, both kinds of outcomes are important.
		DR. LANGER:  Just to circle back, so then at the next meeting, the type of suggestion that Ed's making, we could expect to see some report along those three things that he's talking about; the bullet points, the c.v.s and letters and publications.
		So I think let's do that.
		DR. SCOLNICK:  As to content, I don't know the field that you are talking about, I'm not trained in food safety; I don't know anything about it.  So I would look to other people on the Board to give you guidance on what the content actually is, the kind of category.
		DR. NESTLE:  I don't know whether this will be helpful or not, but can I make a few remarks about ‑‑ 
		DR. LANGER:  Sure.
		DR. NESTLE:  ‑‑ the committee, since I was on it.  It was a year ago and it's hard to remember the details, but I came away from it with several impressions that maybe would be helpful in this context.
		One was the absolutely vast scope of CFSAN's mandated responsibilities.  The range of research that the agency is required or has gotten involved in, and I'm not sure what the requirements are and what the self-selected involvements are; but when somebody says "add biotechnology on top of that" I'm just shocked at the idea that you would need to add another area of research on top of what is already enormous.  
		We sat there for three days and listened to people talk about research on every conceivable aspect that the agency regulates.  You can't think of anything that wasn't there, and then people would say, "Well, are you doing research on immunology?  Are you doing allergy research?  Are you doing biotechnology research?"  They need to do all of it but they can't.
		The initial starting point was, we weren't allowed to talk about resources.  So we were proscribed from mentioning the word "resources" although it was impossible to sit there for three days and not think about it constantly, because it's perfectly evident that the agency doesn't have the resources that it needs to carry out its mandated mission, let alone what people think it ought to be doing if the science was going to be where it should be.
		And that's why the issue of focus kept coming up during the review, and it came up over and over and over again.  What's the agency's focus?  What's the purpose?  What are the priorities?  Every single group that reported on its research was asked by somebody on the committee, "How do you know what your priorities are?  How do you set your priorities?  How do you determine your priorities?"  And nobody had any satisfactory answers to that.
		Then very little was said about Congress perhaps because this was a very polite agency review, but Congress has had a great deal to say about FDA is doing, and just in the area of dietary supplements, because I'm a follower of what's happening in dietary supplements.  I read the Federal Register.  I can't imagine how many people you can have writing Federal Register notices just in response to DSHEA, FDAMA and Pearson vs Shalala.
		I mean, it's just astounding to keep up with that, and so if Congress is going to insist that the FDA do these kinds of things, and the Science Board wants the science to be of a quality that it really should be.  I think there's a real problem, and that the major issue has to be to determine the priorities and focus.  Where is FDA able to do what no other agency can do?  What can't his agency do that nobody else can do?  Everything else needs to be farmed out.

		DR. SCOLNICK:  I don't think ‑‑ comments I made are inconsistent with you.
		DR. NESTLE:  No, they're not at all.
		DR. SCOLNICK:  I think it's what you can do here, what you take from the rest of the world in a science field, concentrate on, and it seems to me that the Science Board can help in whatever argument it has to make with Congress, whatever.  A significant outside view.
		DR. NESTLE:  Let me just make one other comment.  The most shocking thing that I learned during the review was that extremely competent scientists are being transferred out of their area of competence to work in areas in which they are not competent, because of mandated requirements.
		That to me was the most shocking finding from the report.  Then there are little things floating through the report that refer to that, but that's something that I think really needs to be looked at.  You have people who are experts in areas that are important from a regulatory standpoint.  If those people are being transferred to the Food Safety Initiative because the Food Safety Initiative is mandated, there's a problem and that needs to be dealt with, it seems to me in a very direct way.  And it's possible that this Board could help prioritize and help the agency deal with those kinds of issues; and it seems to me that's the most useful thing that we can do.
		DR. LANGER:  Excellent points.
		I want to take a minute, there was one other set of issues that came up, which is the peer review, not only for this group but for future groups, and I wanted to get, Bern, your comments on that.
		DR. SCHWETZ:  We continue to talk about what the sequel should be to having reviewed CBER and now CFSAN, and I want to say a few words about where that is relative to the recommendation, the last recommendation in the report, that guidance would be provided. 
		We continue to think that there may not be just one model for doing peer reviews that would fit all the parts of the agency, and the review process for CBER was different than was used for CFSAN; and there are several parts of the agency that are talking about peer reviews now, at just the first thinking stage, and that would be for a review within the Center for Drugs, the Center for Devices and Radiological Health, and CVM in particular; ORA will take its turn as well, and so will NCTR, but those three are the ones that are actively discussing right now.  What should they be doing in their centers as a follow-up to what's happened in CBER and CFSAN?
		Let me come back to one of the things that Dr. Henney has stressed so many times when she talks about the science of the agency.  There's a tendency often in the minds of a lot of people to think the science of the agency is what goes on in the laboratories.  That's not the science of the agency; it's a very small part of the science of the agency. 
		The majority of the science has to do with the regulatory decisions, the review science of the agency.  Then you've got the investigation and the inspection part of the agency that's also science.  Must be science based, but it depends on the technology that we have in the rest of the agency to carry out that part of it.
		So you've got a review function, the laboratory research, non-laboratory research, the investigation part of the agency.  Of the 9,000 roughly people we have at the agency, we estimate that about 6,000 are involved in science.  So when we review the laboratory component, we're reviewing an awfully small part of the science of the agency. 
		We do that because we know how to do it, because there's a precedent for how to review laboratory work.  It's been done in NIH, it's been done in a number of parts of the FDA on a regular basis; NCTR has had an ongoing review ‑‑ because that whole center is research, there's been an ongoing science advisory board function for many years.  Division by division, we've also done it under Drag's evaluation, under his help -- the whole center.
		But if we only review the laboratory component of the FDA and we say that we have a peer review system, it's a bit ingenuous and misleading, because that's not a peer review of the science of the agency.
		So one of the things that we're talking about when we are having these discussions within CDRH and CVM and the Center for Drugs is how do we do a review that takes hold more of the science of the center?  And as a result, we will be coming up with a different approach as we look at these other ones that will be different from what we've used in CBER and in CFSAN, just because their centers are different, and we're trying to figure out how to get our hands around this larger part.
		As we've talked about how to review the review part of the centers, while at first thought it sounds like you ought to be able to do that, you ought to be able to look at the quality of the science that was behind the decisions that we made.  But one of the difficulties is, who do you get to peer review them?  Because the people who know most about it are the people whose products were being reviewed.  And you can't bring them in to do the peer review of the decisions; that just wouldn't work.
		If you bring others who know a lot about it, they're from another company and do you want them to do the peer review of decisions that were made on another company's product?  Academicians are often consultants in this process.
		So by the time you go through the list of who's available to do this, who isn't involved in some way, you end up with a short list of people who may not be the experts that you want to do the review of the review function.  We're struggling with that yet, and there must be a solution out there, but we're trying to figure out a way that would meet the characteristics of a good peer review that's not biased but is serious in its ability to review the science of the regulatory decisions.
		So in terms of the reviews that we're looking at in addition to those three centers that I've mentioned, we have also talked about an in-depth peer review of all of the work that's being done under the Food Safety Initiative.
		Again in that arena, the laboratory research and the cooperative agreements that have been part of that, and the other mechanisms to get research done, that's not all the Food Safety Initiative.  There are outreach programs, there are educational programs, there are other parts of the Food Safety Initiative that we're trying to figure out, should we review the whole thing or should we review just the research and the research planning, and what's been done?  But that's another peer review activity that we will bring to the Board when we figure out how we want to review them.
		Just one closing thought. In terms of how to provide guidance, I would ask that if this reported is accepted and that recommendation is left there, that you allow us the flexibility to not be too specific about how that guidance should be; or word it in a way so that it can be used in a variety of models for doing peer review; and it doesn't limit the flexibility and the future of how the peer review would be structured.
		DR. LANGER:  There were several comments.  All four of you.  Go ahead.
		DR. NESTLE:  I was going to say that I absolutely second, after going through this process, the need for instructions on how to do it.  So that it's very clear that the chair of the committee and the agency know what the objectives of the review are before the process starts, so that people don't come in and talk about the details of their research when the review really wasn't of the details of their research.  And most of the time spent in the review was having people talk about their research and equipment, when that really wasn't what this was about.
		So I don't think it needs to be spelled out in that kind of detail; but the objective should be clear.  And the review process should be designed to meet those objectives.  Is that fair?
		DR. FENNEMA:  Oh, that is absolutely fair, yes.  And I think the element of self-analysis is something missing that is absolutely essential; that the group being reviewed needs to sit down probably for a day or two, and decide in their own minds "Hey, how can we do things better?"  And to present those proposals in written form to the review committee.
		The outcome of that is going to be much, much better than what we were able to do this time.  A very beneficial process.
		DR. LANGER:  I'm going to get those other comments in a second, but I'm just wondering whether Bern, it sounds to me like we're talking about minor wording changes, and whether you and Owen could just maybe during the lunch break or a break work on what that wording should be.
		DR. SCHWETZ:  I'm not so worried about wording as I am the concept of how extensive that guidance would be. 
		DR. FENNEMA:  Well, this certainly, I think ‑‑ put it this way.  There is a role, a very clear role for the group that's being reviewed and the management of that group to have a voice in the emphasis of what's going to be looked at during that review process.  And in essence, some of the details of that.
		This group I think has a distinct role in setting general guidelines for how these are to be done.  This self-analysis, for one thing; the agency had no awareness of the need to do this sort of thing.  The point that Marion had just mentioned, the fact that we spend probably 40 percent of our time listening to the details of various research programs within the agency, and that's not what we wanted to hear.
		What are our problems?  What are your suggestions for overcoming these problems?
		DR. NESTLE:  How can we help you?
		DR. FENNEMA:  Yes, how can we help?  That's what the focus should have been, and that's the sort of thing that needs to get into these review guidelines we're talking about.
		DR. LANGER:  Of course one thing could be done ‑‑ this is just another thought that I've seen in some cases ‑‑ that you almost have a pre-meeting, you know with the committee chair and maybe yourself and maybe you, and you try to figure out an agenda and a program.
		DR. FENNEMA:  That's excellent, and that's part of thing you can put into this little guideline.  
		DR. BUCHANAN:  Certainly based on the experience we acquired as a result of this process, if I might have gone through it, I wouldn't do it necessarily the same way again.  I think that there were some differences and expectations that you had versus what we had.  And certainly I think having been through that now, how do we know how to avoid those differences?
		We also had some expectation in terms, and I have to say that they were articulated ‑‑ at least the instructions that we got that were articulated ‑‑ that even though the focus of the risk assessment was on research planning, et cetera, we had some expectations that there would be at least some discussion of the programs in providing an overview of what we actually do in some of the areas that we have active research programs in.
		So it was again a balance of, our interests were in the management of our higher program, but there was certainly some expressed interest in providing you with some details about actually what that program encompassed, and that huge breadth of activities that we're involved in on a day-by-day basis.
		DR. FENNEMA:  But there were some very clear misunderstandings in terms of what the expectations were in the process.
		DR. BUCHANAN:  Everybody tried to make the best of it; I'm not being critical of anybody.  But it would have been so helpful, if these guidelines set down well in advance so that everybody knows "Well, here's what's expected of us."
		DR. LANGER:  Are there some other comments?
		DR. DAVIS:  It sounds like ‑‑ or two comments.  One, not having been on this particular review board ‑‑ in the past I've served on quite a few, especially for these governmental reviews ‑‑ it's dangerous if one gets too much in the details of the science as opposed to the direction and policies of the institute.  
		Because what you will have is people sitting on this side of the board who often won't understand the science ‑‑ I mean, you're the experts in what you're doing in your lab, and so you stand there and you tell us all this great and wonderful stuff that you're doing in terms of the details of your science.  We're sitting there, they were probably sitting there not knowing where that was.  Rather, we're probably best helpful in terms of your vision, your direction, your policy, et cetera.
		The second point I would make, somewhat echoing Marion's comments to sort of merge Dr. Scolnick's comments ‑‑ I spent 20 years in the Air Force doing research, and if you look at publications, we often rarely published anything because they went into military kinds of journals or they went into tech reports.  So if you ask for a list of the things that have been published, a person could be very active in his or her field, doing excellent work, and yet have very few publications.
		I think this summary that you mentioned --
		DR. NESTLE:  Federal Register notices count. 
		(Laughter) 
		DR. DAVIS:  Yes, but I think this summary that you also mentioned in terms of ‑‑ what is this person doing and how is this impacting the science?  The list of publications might be small, but -- 
		DR. SCOLNICK:  That's just a small part of ‑‑.
		(Simultaneous discussion)
		DR. DAVIS:  We're not going to shortchange ‑‑ if it turns out there's only one publication of three, but what's the impact?
		DR. COLWELL:  I'd like to bring another perspective.  I feel very strongly that research does belong in the FDA.
		Obviously you can't do all that you need to do when the source is out there, but there is the partnering with other agencies that can be done more effectively.  For example, the genetics of drug resistance.  The NSF funds research on this; not that we would direct the research specifically to meet your needs, but certainly much of the research that we do could meet your needs; and it would be very helpful, I think, for some of your key scientists to talk to some of our staff so that they know what these needs are, and that when proposals come in that do get funded, that there could be some interaction between those investigators and your investigators.  So that there could be a synergy that could be very effective for the FDA in getting the basic research knowledge that you need and to apply it to the problems that are very real and very relevant to some of the directions that we have.
		Secondly I would suggest that you might want to take the model, Bob, of the National Science Board.  You raised the issue of the science of regulatory decisions, and having to do science and that.  Perhaps at this point the Science Board for FDA could develop for you a position paper with maybe two or three meetings of folks who are expert and to provide them the kind of guidance which gives a strong justification for the direction in which you go and then you can couple that with the internal review of the sort that has been described, and which I concur, namely self-study and identifying problems; and then the Science Board would then have a position paper. Between the two efforts you have a very strong justification either for arguing, not only successfully but try, arguing for new resources.  You would have a very strong underpinning for that request.
		So it seems to me that a board, this board, could truly be a very strong and powerful science board for the FDA in some additional ways than we think pursuing the cost.
		DR. LANGER:  We're running a little late, but why don't we take a couple more comments.  Ed?
		DR. SCOLNICK:  I think I'd really like to applaud your direction to review the science of the majority of what FDA does, which is the scientific review of product applications, issues that affect the general health of the public. 
		I think that's a really important part of what you're undertaking to do.  I'll make a couple of comments; one, just picking up on what Dr. Colwell said. 
		In today's world, with the technologies that exist to share information globally, the agency doesn't do everything itself; it really needs a system to be able to access globally what everyone in that field is doing.  And the redundancy and waste, frankly, in the global regulatory process that today is not taking advantage of that in a global sense, is staggering, if you were to stand back and look at it.
		I think if the FDA took a leadership position and tried to change that entire process by virtue of what it does in getting information that it needs, it could really improve itself into the whole process globally.
		Secondly, I think you can have, you have a very effective mechanism in place in FDA, which has worked really quite well over the years; and that is, you have these external review boards which you bring in to review the company, and they're made up of academic scientists from, in theory anywhere in the world.  I don't know what your regulatory guidelines are and who you can populate those boards with, but there's no real reason you can't do that in yet an additional level to review with permanent, rotating, temporary rotating periods of length that give some substance to it.  Really senior scientists from around the world who could come in and help you review the science of your regulatory process, who are therefore not tainted, because for those periods of time they are not consulting with anyone and are not part of any other company.
		If you use that concept, which has been extremely effective, extremely effective, you can review your regulatory processes ‑‑ something like that.
		DR. COLWELL:  Can I make another addition.  Because together, fit with a position paper that can be part of your Science Board.
		Let me just take the area of biotech, for example.  There's an interagency movement toward developing a microbial genome program, interagency for the government.  Looking through reports and data, it would be extraordinarily helpful to have the full sequence of Listeria, for example, and a few of the other number one pathogens you've got. 
		It may not be something that you could get funded by the FDA alone; but if it's known that this is a top priority bacterium and if you're at the table discussing the priorities, we could get these done and in that way enhance your capacity to do the kind of work you need to do.
		DR. BUCHANAN:  I feel I need to jump in and make some comments, and what is not actively reflected in the report ‑‑ largely because we probably didn't actively focus on it during the review process is that our scientists are heavily networked and rely on the basic science that takes place through your organization, through NIH and the Department of Agriculture, we have very formal and very informal ties to all of those activities.
		So for example your suggestion about the Listeria genomics, this is a project that's actively being done by Jacqueline LoHorr in France currently at the Pasteur Institute.  She is already doing this.  
		We have, and one of the reasons why the President's Food Safety Council tried to develop this, this Joint Institute for Food Safety Research, is to make sure that we're not having a great deal of redundancy across federal agencies, but that it is a coordinated activity.
		So for example, we have a need for more information in order to contemplate standards for microbacteria-impaired tuberculosis.  We have gone to NIH and we continue to sit and are aware of all of the research in that area that NIH is doing.  At the same time we have formally requested of the Department of Agriculture because they have certain ‑‑ they have farms; we don't.  That they conduct certain types of research in microbacterium tuberculosis and its thermal resistance.
		By actively seeking all of these opportunities for leveraging, we know fully well that there's no way in the world we would ever get the kind of research budget that we would need to address all of that myriad of questions that were faced.
		So we focus our activities into working with each of those groups to get the basis sciences, taking up the basic science where there's a gap that we need to address.  And then being able to take the resource from all of that, do the applied science that we need to do in order to get our regulatory mission addressed in a timely manner.
		DR. COLWELL:  I think that's laudable and I'm glad to hear it.  What I'm saying is that I think there could be even greater communication to your benefit, then you probably deserve a seat at the table where these discussions are going on, rather than just a pipeline to it.
		MR. LEVITT:  And any way you can help us get that seat at the table, instead of a pipeline going in, you know, we ought to take advantage of.
		DR. BUCHANAN:  Right.
		DR. COLWELL:  That's why I stay on the Science Board.
		DR. LANGER:  Why don't we take two fast points.  Go ahead.
		DR. DOYLE:  I was also on the committee, the review committee, and I think we found an awful lot of areas where there are opportunities for improvement.  But I personally want to commend both Mr. Levitt and Dr. Buchanan for what I think is an incredible they have done in just two years in advancing the agency as far as it has.  
		They're the leaders, and when Bob Buchanan said FDA, CFSAN is the leader in the area of quantitative microbial risk assessment they are, they're leading the world in that area.  They brought that concept to the agency, and I think this is an approach that's truly needed to specifically address what needs to be done to enhance food safety.  It's not just being a cop anymore, but it's actually taking a scientific approach to this.
		I commend them both, and I think we really need to recognize, they have made a lot of contributions in just two years.  They're looking for more ideas on how they can do it better.
		DR. LANGER:  Harold?
		DR. DAVIS:  Just a quick point.  Better than mentioned the, how do you structure the review panel for regulatory issues?  I don't speak for all of industry, but clearly we would not, at Amgen, want to see someone from Merck looking at our package, et cetera.  But when it comes to the consultants, I think most of us recognize, when we get leading consultants, that you're consulting for a whole host of groups; and so that's just a given in the industry.
		But if you use top name people, that they are already looking at SmithKline and Merck and whatever.  We have confidentiality agreements with them.  In fact, one of the reasons we go after the top people is because at least they have a background in what's going on in the industry already, and what is going on at the agencies around the world.  So that's a given with us as it relates to consultants.
		DR. LANGER:  Let me, just two quick points, because I wanted to see if I could get a motion to accept this report with the caveat, though, that Bern and Owen might just work on that, exactly the wording of the issue of peer review.  I think the spirit of this is ‑‑ is there anybody who would make such a motion?
		[Moved and seconded]
		DR. LANGER:  Motion to approve?
		[Show of hands]
		DR. LANGER:  A second just before a break, you wanted to introduce ‑‑?
		DR. SCHWETZ:  Just to introduce people who came in since everybody was introduced earlier.  Dr. Colwell, welcome, glad to have you here.  And Dr. David Feigel, the Director of the Center for Devices and Radiological Health.
		DR. LANGER:  So with that, I'd like to take a ten minute break and be back say about 5 of 11.
		[Recess.] 
	CFSAN's Dietary Supplements Strategic Plan
		DR. LANGER:  We're going to get started.  So Joe, are you ready?
		MR. LEVITT:  I'm ready. 
		DR. LANGER:  Be seated, please.  Joe Levitt's going to talk about CFSAN's Dietary Supplements Strategic Plan.
		[Slide]
		MR. LEVITT:  I'm going to take a couple minutes before I start going on dietary supplements, and give you a little background of how we got there, and tie in some of the comments that were made in the previous discussion.
		When I became the center director a couple years ago, I had the same reaction Marion Nestle had, which is "Oh, my gosh, how are you going to do all this stuff?"  And one of the first things we did was we developed what we called our 1999 Program Priorities document.  We provided this to the review committee.
		Since at the end of the year we actually put out what we call our report card on the document ‑‑ I'll get copies over lunchtime and bring it to folks if you're interested -- which shows that we accomplished nearly 90 percent of the objectives that we had laid out during the year.  And we felt quite good about that, good enough that we had the courage to go the year 2000 priorities, which is patterned after the 1999, even more ambitious.
		So we feel at least we've got the program in a direction.  One of many items, one line of this entire book was to do a dietary supplements strategic plan, and I want to talk about that. 
		But I am going to do one other quick prelude, if you'll go on to the next slide. 
		[Slide]
		Which is, as we have been working through the center, we have joined on our senior staff and decided that our overall mission, the specific priorities are good and important, we did a page back and say our overall mission is we want to be building a world-class organization, and that there's three principle components.
		The first is that ‑‑ the first is backwards [slide].  But I know it well enough that I will tell you what it says; that we need to have a strong science based-program for our decision making.  Unlike all decision-making.  I know that this Board will agree with that; that we need to have a strong science-based process for informed decision-making, and that has to underlie.
		So as you look at our priorities document, know that there is a strong science foundation under every one of those.  We'll see if the next one is like that.
		[Slide]
		Number two, we have the operational capacity to implement the decisions we make in a timely way.  I think historically CFSAN has done actually very well on science base.  We've heard some of that, yours leading to strength, and also this is an area we, as well as a lot of FDA, have a lot of work to do in terms of being able to follow through on the decisions we make in a timely way, and the priorities document is one way of helping us do that.
		[Slide]
		The third is to develop what we call a culture of accountability, cooperation and respect. We want to be sure that we are accountable and are held accountable for what we try to do.  But we also realize that we can do that in a way that reaches out to people, both externally and internally, and shows respect for others, for ourselves, and for the law in which we operate.
		So you take those three things together, take the strong scientific foundation for decision-making and operational capacity to follow through, and a culture of accountability, cooperation and respect, and we feel that is going to help us build a truly world-class organization at CFSAN; and we have dubbed that what we call our new day.  And a new day simply means what's past is nice; what's future is what is important; it's a new day and we will do whatever it takes in order to accomplish our mission.
		[Slide]
		So that's kind of general background surrounding all of our programs.  Let me take that now and go into the Dietary Supplements Strategic Plan, and we'll see if it fits.
		[Slide]
		What I want to do here is cover four main points; (1) why we set about doing this in the first place; (2) talk about the public outreach process that we had; (3) a summary of the plan; and (4) the next steps, where we're going to go from here.
		[Slide]
		Okay, why develop this plan?
		[Slide]
		About a year ago, a little more than a year ago, Dr. Henney had the good opportunity, as we say, to testify before Congress on the subject of dietary supplements.  We all kind of hustled together to figure out, "My gosh, the law was passed five years ago."  The theme was that FDA hadn't done very much, that was kind of the image around it.  And went back and said, "Oh, I guess we haven't done much, we only published 25 Federal Register notices during that time."  And that juxtaposition was kind of odd because that would have been viewed as a lot having been done.  But against what was needed, it was clear we still had to do much more.
		What we actually lacked was a clear road map of how we were going to approach this law.  The law had been very controversial; the law is a different kind of law than our law was that FDA has to operate, and that is mostly a postmarket law not a premarket law; and we dedicated ourselves ‑‑ in the course of this year, one of our items was, we would develop a strategic plan with public outreach, how are we going to approach dietary supplements, can we do that in a collaborative way with outreach?
		Now Dr. Henney had three statements I'll just read to you quickly that came out at that hearing.  Number one, FDA is aware that Americans place great faith in dietary supplements to help maintain and improve their health, and that the scientific evidence documenting the benefits of a number of supplements is increasing.
		So number one, the law is that dietary supplements is here ‑‑ there's a lot of interest and there's increasing science evidence behind them, so let's move forward. 
		[Slide]
		Quotation number two is the challenge to FDA is to strike the right balance between preserving consumer's access to products information while at the same time assuring the safety and proper labeling of all these products.  So not only do we have to maintain access but assure safety and proper labeling. 
		[Slide]
		And the third is it is clear, therefore, with the benefit of hindsight, we still have a way to go in achieving full implementation of the Dietary Supplement, Health and Education Act, what we call DSHEA, and of developing a workable regulatory framework.
		We started with public outreach, and let me tell you what we heard.  
		[Slide]
		We had actually two meetings; one was in Washington, one was in California last summer.  I chaired both meetings myself.  We also got written comments, and there were a lot of themes in terms of what we heard.
		Number one, at the first meeting, frequently mentioned, almost everybody said "deal with safety first."  That's quickly followed by, as part of that, "Get your adverse event reporting system in shape."  We have a system that is earlier in its development, I'll call it, than what you have in drugs or biologics or in medical devices.  Get good manufacturing practices in place, strengthen your enforcement.
		And actually the one thing that was a surprise to us, certainly not ‑‑ but a surprise, is increasingly a number of calls for enhancing the science base under these products.  And that was music to our ears, but I'll tell you, it was a bit of a surprise.  There were a lot of different ideas how to do that, but there was a clear theme; you've got to enhance the science base under these products if they're going to have credibility in the marketplace. 
		[Slide]
		There were an additional number of things that also emphasized you need to clarify what you ‑‑ how you have to substantiate claims, a lot of call for increased consumer research on how consumers read labels, special emphasis on botanicals and again need for collaboration, and both need for sources, but also for leveraging resources, much of what we've heard earlier this morning.
		So that was kind of the first meeting.  We then went to the second meeting out in California.  And we had actually a different kind of meeting, significantly.  What happened I think was that the health professional community, particularly the medical community, realized they were not represented at the first meeting.  You know, we put out our notice, "people come."  The outreach wasn't very good in that area, but they heard that they weren't there, and they came by in droves to the second meeting.  And we heard a very different message from them.
		We heard concern after concern after concern.  "We don't believe in the safety of these products.  We don't believe the claims are valid.  We don't know what's in them, and what FDA's job ought to be ought to be to tell the public that these products are lousy, and it is a buyer-beware world."  That was the message we got for about three or four hours.
		[Slide]
		We also had a number of consumer panels that included a parent of a victim, of a college age young man who had just died, and that had its own imagery around it as you can understand; there was a strong message of buyer-beware; a call for what they called a Consumer MedWatch for adverse event reporting, reflecting ‑‑ we had not adequately conveyed that consumers can submit adverse events to the existing MedWatch.  So there is an existing consumer medwatch, but people clearly were not aware about that.  And especially concerns about marketing to elderly, to women, to children, to populations that are perceived as vulnerable or willing to take these products with greater risks, and with women, particularly pregnant women, was emphasized.
		[Slide]
		So you kind of had really two different meetings.  There was also out there a number of things that were the same, and once you got by that, there were the same themes; food safety first, adverse events, enforcement, science-based claims and substantiation.  And again GMPs and on down the line.
		So you had a residual common theme, but I really felt you had to take these two meetings and kind of put them together.  What we did was we tried to put them together and first develop five --
		[Slide]
		‑‑ internal strategy teams around these simple categories; safety, labeling, boundaries, enforcement and research, and that ended up being the framework for our dietary supplements plan.
		[Slide]
		 As we went through the meetings ‑‑ and this is actually a slide I used about last September for meetings in the summer and a plan that wasn't yet out.  But it was number one clear that this was going to be a long-term implementation process, that we have a growing now multibillion dollar industry that is all over the place, and a lot that needs to be done to try to get that under proper control.
		Number two, that science needs to be much more central to this whole area.  A lot of what happened in the earlier days of dietary supplements is to me what I just call product sales.  You know, you can buy the product, and you sell it.  And you rely on whoever sold it to you to worry about the science behind the product.
		There is a growing recognition that that's not going to work over the long haul, that there needs to be a much stronger scientific basis to this entire area.
		Number three clearly will require resources, a substantial amount.
		But four, a blueprint development is fully achievable.  This is something we vowed coming out of those meetings we could do.
		[Slide]
		And this is what we came up with.  We came up with a plan to cover your books that looks like this ‑‑ you notice, I like different colors for my covers.  
		[Slide]
		We came up with four program objectives.  Number one, that we wanted to, needed to fully implement this law, and there was a lot of noise around whether FDA likes the law or doesn't like the law, and I say "You know what?  It doesn't matter, it's the law.  It's a new day everybody.  Wake up, realize we've got a law we've got to implement, let's figure out how to do it.  We've got to fully implement the law."
		Number two, the goal needs to be to provide consumer confidence in the safety, composition and labeling of these products.  And that's what I call by putting ‑‑ that was the message, really, out in California.  We don't have confidence in the products; people express it in different ways. 
		Well, consumers ought to have confidence in these products, as they have in all other products.
		Third, we need to have a strong science-based regulatory approach.  That is what has made FDA successful in every other area we've been successful; we need to take those lessons and apply them here; and Fourth, we have to recognize this is going to be a long-term effort.
		[Slide]
		Now, interestingly when I put this out, you never know the things that you do that kind of come back at you very quickly.  On the cover of the plan ‑‑ some people never get past the cover, you know?  The cover of the plan says Dietary Supplement Strategy, 10-Year Plan.  And the first question I got was:  Why is it going to take you ten years?  
		Well, I made the mistake, the first person I talked to I knew well, and I was a little too flip and I said "Well, we really said ten because we didn't think twenty would make it past" ‑‑ 
		(Laughter) 
		Their reaction was, why not a two year plan, why not a three year plan?  Why is it going to take you forever?  That unfortunately has been interpreted that "we're not going to do anything for ten years," which is not the point.  But the point is number one, we have to be in this for the long haul.  This is not something like the food label where I was also very involved with years ago, an important new law, massive effort.  But once you get that new food label done and on, you kind of go on to a lot of other things.
		This is a program that is going to be with us, more like the OTC review program, or like medical device amendments; this is a whole product area that is just going to grow and grow and grow.  So one thing I wanted to signal, and didn't do it effectively enough, is we have to be there for the long haul.
		Number two, we are going to have to find a way to get the resources; they have dedicated staff.  When I say that, it's not that the staff that work there were not dedicated; both of them are, but we need a full staff ‑‑ we need a full staff just like any other program you have that's effective.  You need a real staff that's dedicated to this.
		And third, and I think this was a mistake that was made at the time, the fact that DSHEA is a postmarket law, meaning you can largely market products without FDA premarket review.  That does not mean it's a low-maintenance law.  Everybody wants to compare this to the drug law, which is a premarket deal.  But if you compare it to the food program, food goes onto the market ‑‑ except for food additives, food goes onto the market without FDA review; and we're the whole center and have our field resources devoted to regulating that as a postmarket program.  So we have experience here.
		But the perception was, because it's not free market, meaning you don't need any resources to do this; it's low maintenance.  Really, there's a lot that FDA needs to do to get the framework in place.  I think it's one thing, if we accomplish nothing else with this ten year plan, it's to articulate what really needs to be done to implement DSHEA in a proper way. 
		[Slide]
		So we took that and we developed our program goal, which I'll just recite here; we put it right at the beginning.  By the year 2010 -- that's that ten year goal ‑‑ having a science-based regulatory program ‑‑ the emphasis on science ‑‑ that fully implements the Dietary Supplement, Health and Education Act of 1994, fully implements DSHEA, thereby providing consumers with a high level of confidence in the safety, composition and labeling of dietary supplement products.
		In that last line, the high level of confidence in the safety, composition and labeling of dietary supplements products is the mantra that I learned to recite again and again and again, because I think that's really what we're trying to achieve.
		[Slide]
		Okay, so you heard that I had five groups put in together.  We just took those five groups, we added them to outreach, and that became how we developed the overall plan.
		[Slide]
		What I am going to do is I am not going to go through every item in here; I'm going to just give some illustrative highlights of what we have in each of the sections.
		Under safety, number one is adverse event reporting.  We really have to get our system at a level of performance comparable to the other systems within FDA.  There is a lot of knowledge in FDA of how to do this right.  And we are making good progress there.
		One thing that is different is that all of our reporting is voluntary.  Interestingly, very few come from manufacturers.  Almost everything comes from health professionals or more even from consumers.  
		So we have essentially raw data that comes in to us.  There is nobody else behind us doing the follow-up, but most drug reports will come in, you know, from Merck ‑‑ Merck has an army of people to go back and follow-up adverse event reports that they receive on every one of their products, I'm sure.  But we don't have that army behind these that come in; they're just raw data that come in from consumers.
		Like, "I had a problem with this, and here are my medical records."  So we have to kind of sort through that, so we have both a, kind of a more sophisticated kind of analysis we have to do, a more complicated.  Happily, we got many fewer reports than we get in drugs than in medical devices, but it's a growing number.  We need to have a system that just has all the basics.  The reports come in, they're logged in, they are redacted, they are reviewed, they are triaged, and follow-up goes accordingly.
		We know how to do the system, we need the bank to resource it.  We have had our request in at Congress last year; it passed the House side, it did not pass the Senate side, did not pass the committee; so we've renewed that request this year.  We feel that's absolutely essential if we're going to get that program running.
		Good manufacturing practices.  Probably the one thing that everybody agrees on is we need to have GMPs, and we have on priority goals to publish our proposed reg this year.  And third, just a notation of new dietary ingredients.  The law does have a provision that new ingredients ‑‑ and new is defined as after 1994 ‑‑ they do have to go through a premarket notification process with FDA.
		As time goes on, as we get more away from '94, there is going to be more interest in that provision.  So there we have to handle like we do, FDA does other premarket provisions.  We have to have the guidance in place, what are the standards, what is the level of evidence that's needed, and that's going to be a bigger issue as time goes on.  There are a lot of other things in the book you see on safety, but those are the three most important.
		[Slide]
		No. 2 under Labeling.  Somebody earlier referenced Pearson v Shalala.  This is a court case that FDA lost in the Court of Appeals that deals with health claims on dietary supplements.  And basically what FDA had tried to do was to set out a standard of evidence that has to be achieved, much like we have in all the other areas you're familiar with, for that claim to be made.
		What the court said was, "Well, wait a minute, why do you need all that evidence?  Why can't you have less evidence and just say 'all the evidence isn't in'?"
		It's a different approach, of putting a qualified claim with a disclaimer.  We had a public meeting on this just a couple weeks ago.  It is of enormous interest in the dietary supplement industry as it is in the food industry as a whole, for potential application in their mind in there.  This is a very challenging area, and this is something you didn't even have a year ago to deal with.
		So this is in DSHEA, but this is in dietary supplements that is a new area that we need to deal with I think very directly and thoughtfully, and where we have a lot of energy devoted to that.
		Number two, we have ongoing health claim petitions; we need to be sure we're able to review those.  And three, we have to start dealing with the issue of substantiation of claims; what is needed to make the claims. That of course plays off into number one in terms of whether a disclaimer is involved.
		[Slide]
		From labeling we go to boundaries.  One thing that DSHEA did not do very well was articulate clearly where the boundary between drug stops and supplements begins, or foods or even cosmetics.  There was a lot of publicity about a year ago; many remember a product called Benecol, which is now being sold as a spread.
		We took a very strong position that that was a food, that it was not a dietary supplement, that it was represented as a food, and the law says it is represented as a food, then it's a food and it has to meet the food safety standards and all the other food standards.  And we succeeded, and the company has cooperated with us.
		That is an example of the boundaries.  We recently put out our final regulation on structured function claims, quite controversial in part because once you clarify the lines everybody goes, "Oh, my gosh, you clarified the lines!"  Of course when you don't clarify the lines, they complain "You know what?  It's all foggy out there.  I don't know where the lines are."  
		So we're working hard at drawing the lines.  We also recently, as part of the Pearson meeting, we had a panel on:  Should health claims include claims for mitigation and treatment of disease?  We have a petition for treatment of EPH with sol palmetto.  Then the question again is, where is the drug line?  Where is the supplement line?  You know, what is the distinction.  
		And a whole host of issues; botanicals, or some would want a whole different class and category for botanical products.  That is something that's well down the road.
		[Slide]
		Fourth is in terms of enforcement.  Everybody agreed, and of course until it's their product.  But by and large, everybody agrees with the principle that FDA needs to have a stronger capacity and presence in order to establish a level playing field.  We are developing both an overall strategy and a lot of effort toward capacity building.   
		One partner who was not mentioned this morning, among many, is the Federal Trade Commission; in this area a very important and a strong partner for us.
		[Slide]
		And finally, of greatest interest to this group is our work on strengthening the science base.  We need to number one be sure that we're enhancing our internal expertise.  Unfortunately we began that process by losing our two pharmacognizsts, which was clearly not by design; and so here we have a ‑‑ if your group came back this year, instead of the c.v.s coming in, I would have to give you the c.v. going out.
		Everybody has their own reasons for moving on.  Actually, CFSAN has a lower attrition rate than most; but we have to establish a critical mass in this program.  And we do not have that yet, and that's I think probably our first goal internally, is to establish a credible cadre of internal experts that can effectively deal with this area.
		We then have to strengthen research efforts, and I'm going to talk more about that in a minute, so I won't do that now.  And third, we have to talk about oversight of clinical trials.  As we're trying to encourage more research, you have to look and see, are there special needs that dietary supplements have that are not appropriate for the IME process but that we should have perhaps a separate investigational supplement process or something, the same that was done years ago for medical devices, when they reach the same kinds of issues.
		So those are the kinds of things we have to look at.
		[Slide]
		In the science base of the research, we need to be working with NIH, with the Office of Dietary Supplements and Center for Alternative Medicine, with U.S.D.A. and others, on developing a long research agenda. 
		One thing, and it was kind of related to one of the comments Rita Colwell had about getting others to do the research for you.  One thing we had done in the food safety area; one of the first things Bob Buchanan did when he came to FDA was develop a long set of research needs.  
		What we found was that by making a list of research needs and making that public that other funding agencies would use those in part as the yardstick on what to fund ‑‑ you know, the system can actually work that way.  And we want to apply that same here.  There's a whole host of needs for research agenda.  Research capabilities, again that's part of our internal science cadre of expertise.  We need to have at least a critical mass within the Center so that we have the expertise to do the science, to have the broad policy and planning.
		Third, we have to look at whether or not we have a retrospective dietary supplement ingredient review.  This was done in all the other areas when FDA inherited a whole product line.  It was done with OTC drugs, it was done with medical devices, it was done with the GRAS review in the foods area.  When the food additive law was passed, and I think that again that will take time, that will take money, but if we're going to do it right, it ought to be done.
		[Slide]
		Finally, probably no area is more important than dietary supplements for the importance of leveraging.  
 		Bob already mentioned the work we're starting to do with the University of Mississippi as an expert center that exists down there.  We want to take advantage of that.  We've already talked again, NIH, Office of Dietary Supplements, Center for Alternative Medicine, in terms of how we can leverage our different work.  In fact, when I went over to NIH, I was surprised but intrigued when their reaction was they feel as overwhelmed as we do.
		You know, we look at NIH and see this huge funding structure and they go "My gosh, our funding structure for our world is tiny."  Just like your infrastructure for your world is tiny.  So we're developing a camaraderie among the different government folks.
		We're looking at NTP through NCTR, what studies, what product ingredients ought to be suggested for review under the NTP program; and so we are ‑‑ again, leveraging is going to be vital to our success in this area.
		[Slide]
		Outreach.  Bob mentioned that we are going to be establishing, as part of a restructuring of the Food Advisory Committee, a separate panel that is devoted to dietary supplements; this is badly needed.  We need to continue our stakeholder outreach and continue very much with open and continuous communication.  
		There are a number of groups here that are not our traditional groups we're working with, and we need to therefore make extra attempts to reach out to them, include them, and be sure there's clarity back and forth. 
		[Slide]
		Next steps.  Where to from here?  Well, what we said is that number one ‑‑ when I said it was a ten year plan I also said that we would articulate each year what we can do that year within our available resources.  
		So in the 2000 priorities document, the R pages, which are dedicated to this year's goal on dietary supplements.  The A list - B list means that A list is the top priorities.
		Within our 2001 budget now before Congress, we have renewed our request for funding for a dietary supplement adverse event reporting system, and we are actively engaged with the developing community buying an involvement to this entire process.  We began about a month ago with a meeting hosted by the National Consumers League, which involved again many of the affected players, who are trying to get people together or do some of the duplication, increase some of the synergy and say again, if we're going to develop the kind of consumer confidence in the safety and composition labeling of these products, how are we going to do that in a way that's efficient and effective?  And that's our goal.
		[Slide]
		In conclusion, this has been I think in many ways a very intriguing process for me.  I've been very involved with this.  I'll kiddingly say that when I first came two years ago and the Food Safety Initiative was so very, very visible, all my first speeches said my top priorities were food safety, food safety and food safety.  And I didn't say it, but probably my last goal was to work on dietary supplements.  At the time the food safety issue seemed so dramatic and huge and compelling.
		Well, even just a year later it quickly became clear that the cost of not paying attention was exceeding the cost of paying attention.  And that it actually would be easier for us if we kind of jumped in and said "Wait a minute, let's grab the bull by the horns and figure, how are going to do this right?"
		So we developed, as I said, a sizeable effort last year with a lot of outreach to say, "How are we going to do this right?"  How are we going to develop consumer confidence.  And then we will take this through our budget process and use it as a basis for building the resource base that we need both inside and outside in order to make the American public proud of this program as with other programs.
		Thank you very much, and I'll be happy to take questions.
		DR. LANGER:  Questions or comments from people on the Board or otherwise?
		MR. LEVITT:  It's interesting because of -- things that hit the media.  This is one of the ones that is just a constant theme.  I tried to be on vacation this week, and Tuesday night there was a Dateline NBC show on dietary supplements, Thursday morning, page 2 of the Post had a big follow-up story on it.
		So it is a continuing theme.  Also, one other thing and I didn't mention this but I should, that we're also calling on all my other colleagues around the table to the left as full partners in this effort.  And everybody within FDA recognizes that dietary supplements is an area of enormous need.  In last year's internal budget process, we've gone to a corporate-wide budget planning process in FDA with different areas like surveillance and research and premarket review and so forth.  And every area recommended dietary supplements as the area of greatest need for this year within FDA.
		So everybody, whether they're part of the program or not part of the program, realizes that this is important.  That didn't make it all the way through the process because of the various things that affect budgets as they go through, but internally everybody is saying yes, this is an area that we want to help.  And so we will be taking advantage of that, too.  But fundamentally, we're going to have to convince the Congress to fund the proper program.
		DR. LANGER:  Yes, Owen?
		DR. FENNEMA:  I would like to   applaud your efforts to develop cooperation with the University of Mississippi.  As you're well aware, the whole matter of dietary supplements is a troublesome one in terms of regulation, but the area of botanicals is an ultra-troublesome one, and there's some good expertise that lie there.
		I think that's a good example of the kinds of cooperative relationships that FDA ought to enter into.  This is going to be very helpful, and I applaud your efforts.
		MR. LEVITT:  Thank you.
		DR. LANGER:  Yes.	
		DR. NEREM:  How well do you feel that you are aligned with the priorities of NIH?  Is it a pretty good alignment or is it still early days, or?
		MR. LEVITT:  I think it's too early.  I think there is ‑‑ when talking with them, a great interest of them in being aligned.  And it kind of comes to the same point that Rita Colwell made before, "having a seat at the table."
		I think what we're developing is a seat at the table and how to be sure that those funding priorities are meeting our priorities as well.  So I say there's openness to achieving it, but there's not yet achievement.
		DR. NEREM:  This is specifically with the Center for Alternative Medicine?
		MR. LEVITT:  Right, specifically.  And dietary supplements, both.  But you're right; the first one has the money.
		DR. LANGER:  Harold and then ‑‑.
		DR. DAVIS:  You mentioned it, but I'm not sure I still understand it, the issue with the Pearson/Shalala ruling.  Would you restate?
		MR. LEVITT:  Yes, I'll restate that.
		As a quick background, FDA has ‑‑ and this is really under the food labeling law from about 1990, a provision for what's called a health claim on a food or a dietary supplement ‑‑ and a health claim is viewed as a disease claim ‑‑ they have been used so far, mostly for risk reduction of chronic disease in healthy people.
		So you see the fiber helps prevent ‑‑ whatever.  That's that.
		When NLA was passed there ten areas, ten specific dye-disease relationships that FDA was to review, for meeting the standard of significant scientific agreement.  When FDA reviewed those, six it said yes to ‑‑ actually seven; I think one was added; and four we said no to. 
		The four we said no to were the subject of this lawsuit.  And we said no because they did not meet what we felt was the standard of reliability.  We actually won in the district court but we lost in the court of appeals, which in the hierarchy of things is the only one that matters.
		What the court said was that it built on a whole series of First Amendment cases in the advertising area primarily.  They said "Well, wait a minute.  What's important to consumers is information that's truthful and not misleading."  
		"We are going to remand these to the FDA to re-review these and say, 'Is there not a way to allow these claims to consumers with certain caveats?  If the caveat is the data are inconclusive, say they're inconclusive.  If the caveat is that these data are only preliminary and more research is needed, write, on the label:  Data are preliminary.  More research is needed following the claim.'"
		With the general direction that under the First Amendment the goal ought to be disclosure first, not what they viewed as suppression.  And that's different from the way we've always done things.  We've always said there is a standard of evidence, and below that you get to do more study.
		But you don't get ‑‑ in fact, we had a meeting of our Foods Advisory Committee last June or so, and in that setting this is called emerging science.  That when somebody says emerging science, I'm told that what they mean is science that's developing but hasn't quite reached the standard of reproducibility and reliability in the scientific community.
		So what this court said was "Well here, can't you take" as I said "the data that are there and qualify them in a way so the consumers have truthful but are not misled to think that they have more than they have?
		So that's what that case is about.  At our public meeting, must have been two weeks ago because I was off this week, we had as I think one would expect, fairly polarizing views on that subject.  You have the side that says "This is my constitutional right to make these claims, and the FDA, every day you're dragging your feet."  The other size says "Wait a minute, consumers are inherently misled if they're led to believe this thing is likely to work when the evidence is really so inconclusive that it really doesn't mean anything clinically.  All it really means is, 'Interesting finding; we need more research.'"
		And those are the two, if you will, polls of view that we have to somehow bring together.  We are in court again on the subject; we've made a pledge to the court to reach conclusions on those four claims within about six months from now; so by next fall we will have reached our conclusion on what to do with the four particular claims.  Meanwhile, there are more petitions that come in that ask for the same --
		DR. NEREM:  Back to the appeals court with these conclusions, or going to a higher court?
		MR. LEVITT:  It actually will go to the lower court.
		DR. NEREM:  Go back to the lower court.
		MR. LEVITT:  Yes.  You have to start again, at the beginning.  The plaintiffs in the suit have already charged unreasonable delay, that it's taken us this long; and want the court to, if you will, hold our feet to the fire.
		DR. COLWELL:  What are the four that you were asking me? 
		MR. LEVITT:  Can anybody recite those for me?
		DR. NESTLE:  Antioxidants is one of them.
		MR. LEVITT:  In back?  Anybody here.
		DR. BUCHANAN:  I don't --
		MR. LEVITT:  My many legions of loyal followers? 
		(Laughter) 
		DR. NESTLE:  One of them is antioxidants.  
		AUDIENCE:  Both of them are not here. 
		(Laughter) 
		DR. DAVIS:  Both of them.  They're dedicated, though. 
		MR. LEVITT:  Very dedicated.  
		I don't want to hear them imprecisely argued, but why don't I after lunch bring it back.
		DR. DOYLE:  Along that line, Joe, remembering the results of the CFSAN review, you are incredibly short a step in this area. And what are you doing with RSAT (ph) to fill a gap?
		MR. LEVITT:  Well, the first thing we do is ‑‑ I made a big budget request which a little bit made through the administration, and we're fighting in Congress for that, devoted to adverse event reporting, and we'll come back again this year.
		There's another thing about FDA staffing in general just for your education, which I have to tell you is bizarre.  And everybody I explain this to says "My gosh, this is bizarre," but it's true.  In that starting about 1992 or '93 when Congress passed the budget balance amendment to the financial laws, FDA got a quote "level budget."  So whatever our budget was, we'll say FDA's budget was a billion dollars.  The next year it was a billion dollars.
		The problem is before that we always got our inflationary increases, what's called "current services" in our financial world.  So we can get current services, which meant FDA had to absorb all the inflationary costs.
		Now in that year, that was the year the Department of Commerce was proposed for extinction.  So we kind of thought "Mm, level budget, proposed for extinction."  I know which one I'd pick.
		So we actually thought at the time we didn't get a bad deal.  We didn't realize until some years later that that became the new rule.  And therefore what happens each year in FDA now is that the programs that have earmarked funding by prescription drug user fees were now Food Safety Initiative, those get if you will protected, and everything else, what's left gets to absorb ‑‑ just a new favorite word; we absorb now ‑‑ we absorb our inflationary cuts.
		What that means is, my program has about $100 million in my budget.  I lose $5 million every year. Every year I have to find $5 million to cut, which means I need more people but I need people to leave to pay the people that are there.
		When I explain this to industry folks they say "I could never run a business that way."  I say "Well, it's just one of the joys of working in the government.  But in Dennis Baker's world, in the field, his cut for the foods program is $7 million.  So every year ‑‑ last year we were very fortunate; we got a $40 million increase, but we also had a $12 million cut.  And somehow we're going to have to find -- us, FDA, we're going to have to find a way to make the needs of that case better.
		I mean, what happens in U.S.D.A. in their inspection service, is they get their increases every year because under their law, if they don't have an inspector in a plant at every minute, the place has to shut down.  So there is a force that is sure that that funding is happening.
		What happens at FDA, a little less happens, a little less happens, a little less happens, and you get nibbled away to death.  And a lot of our programs are being nibbled away to death.
		The good news is with this earmarked funding, it's been sizable, it's been substantial, and used well.  But the silent part of that is these other areas are just less and less and less and less; and so our first role is to try to find a way to broaden funding so we can use new funds more broadly across the board with more flexibility, but also to find some way to deal with this constant erosion of current services and inflationary costs.
		It's a real struggle that all my colleagues around that side of the table share equally.  We finally find something we all agree on, you know.
		DR. LANGER:  One last question.  Well, we'll take two.  Go ahead.
		DR. SCOLNICK:  Are there implications of this case for how you deal with safety issues?
		MR. LEVITT:  The case presumes safety.  If we thought there were safety issues, then that could be an effective reason for us saying no.  The presumption on dietary supplements is that they're safe.  There's a quote "history of safe use"; that was kind of a congressional declaration.  One thing you see with all the publicity you hear around Ephedryl is what the government has to do in order to make the safety case in terms of taking adverse event reports, not having a prior body of clinical trials, and kind of filling it from scratch.
		But if there was a safety issue, that would override the issue of claims.  That is an issue of efficacy with presumed safety.
		DR. SCOLNICK:  It seems to me in the future as you articulate it, a bigger problem I think is really potential safety issues; because there isn't the body of clinical data.  The safety issues, it seems to me in the longer run, the bigger issue is the safety expanse.  And trying to figure out a way that you could partner with departments of epidemiology and public health and ‑‑ 
		MR. LEVITT:  Or poison control centers is another one.
		DR. SCOLNICK:  Poison and et cetera, because to me that's the much bigger issue.
		MR. LEVITT:  Yes, safety first.
		DR. COLWELL:  But even basic research can be helpful here, because understanding the actual components, the molecular structure and so forth can be valuable.
		MR. LEVITT:  It's hard to imagine anything that we did that would not be helpful.
		DR. COLWELL:  Yes, that's true.
		DR. LANGER:  One last question.
		DR. NESTLE:  I'm teaching a course in dietary supplements this semester, so this is a subject of great interest, and I don't think it's possible to be too cynical about what's happening in the marketplace, in Congress, in the courts and everywhere else in this field.  And this is not something, given the number of products that are out there, this is not something that anybody is going to get a handle on very easily.
		I have one question for you; and that is, what can the Science Board do that would be helpful in this situation?
		MR. LEVITT:  I would say help us identify areas of leveraging, universities, the seat at the table at other agencies; because for the scientific underpinning, the best thing we can do is to leverage what's going on anyway, and not wait for Congress to see what they will fund.  I think that's the number one thing you can do to help us.  Places like the University of Mississippi that we should be developing partnerships with and collaborate.
		DR. SCOLNICK:  Do you want a statement from the Board or something ‑‑? 
		DR. LANGER:  What would you like from the Board?
		MR. LEVITT:  Uhmmm.
		DR. NESTLE:  He's not allowed to say.
		(Laughter) 
		MR. LEVITT:  "I'm here from the Science Board.  I'm here to help you." 
		(Laughter) 
		DR. DAVIS:  I think it seems to us that when those kinds of decisions were being made, and FDA is standing there with its own bias, obviously it's viewed by the public or the consumers or these companies that a note from the Science Board saying that, from a scientific standpoint, you know we are concerned, if we are, about these kinds of decisions that are being made.  That comes from hopefully recognized scientists, a variety of areas, disciplines, et cetera.
		DR. SCOLNICK:  Or that we support X and Y initiatives.  And try to make them specific enough that it doesn't --
		DR. SCHWETZ:  Give an example of something that might be helpful.  One of the fears I have with dietary supplements is that because the rate of attention, the change in attention to this is going so rapidly that we're going to jump right over what homework should have been done, and jump right in to trying to solve questions for which there is no background.  And it's very tempting to do that as opposed to saying "Those questions are real, we'll get to them when we have a database to be able to handle them."
		What we ought to be focusing on now has to do with all the questions ‑‑ what are the active ingredients?  What are the components?  What is the reliability from one product to another?  There's a whole bunch of homework that needs to be done before we begin to say "This is safe and that's not safe" because we can't effectively do that yet.
		And one of the recommendations could be to reinforce that the agency would work on the science underpinnings of decisions that need to be made about dietary supplements, so that it provides long-term guidance in this area.  This isn't going to go away in the next two or three years.
		DR. LANGER:  So is that something that would be useful to be able to say today?  I mean, we could certainly, you know, make a simple statement like that, or would you like to come back to us next time with some other things that you'd like us to do?
		MR. LEVITT:  The two are not mutually exclusive.
		DR. LANGER:  No, they're not, at all.
		MR. LEVITT:  I would say certainly in terms of today, and I feel uncomfortable putting words in your mouth.  I'd rather --
		DR. LANGER:  Well, you make a statement; we'll change if it we like to. 
		(Laughter) 
		MR. LEVITT:  But, you know, any statement from a board of this stature reinforcing the importance of scientific decision-making in all these areas of dietary supplements is critical, and that FDA needs to have access to the kind of scientists and the kind of expertise that is going to allow us to make the decision the law charges us to make.
		That is what is most at its core of what we're trying to achieve here.  And any other practical suggestions you have.
		DR. DAVIS:  I guess I'm a little uncomfortable with the discussion.  In the past, serving at the NTP, NCTR, et cetera, one of the things we always identified were potential reporters in the audience, et cetera.
		So I guess I appreciate your dilemma, standing there when we're talking back and forth about ‑‑ to do.  I think personally any comments ought to come from the Board --
		DR. LANGER:  Oh, absolutely.  I just wanted to sort of see, I think the motivation of asking the question was to understand what would be helpful to you and then we would move from there.
		DR. SCOLNICK:  I think again, just coming back to the safety issue ‑‑ to me, trying to define the components, as Rita said, the actual components that people are putting into things, and trying in the shorter run to ensure, based on whatever elementary science you can bring to bear in the short run, that what's being done is safe and is not going to have a long-term negative consequence for literally thousands or larger numbers or smaller numbers of people is in my view even more important than validation and the scientific evidence that's doing good.
		Because as long as it's not doing harm and there's some sense in a consumer of what they're doing or not doing, that's important, I think.  Working out the scientific evidence to prove that these things are effective in the long run is an enormous undertaking.  We're trying to ensure the safety, that some ingredients are not being put in as dietary supplements that are actually harmful to lots of people I think really should be ‑‑.
		DR. LANGER:  I think these are very important.  I want to close the session up because we're running a little behind.
		Let me make this suggestion:  how about if Bern and you and Marion could maybe have a conference call at some point in the next few months and get back to us with sort of a broader set of statements about what the Science Board could do.  And from that we'll try to formulate some statements and some other things.
		Would that be okay?
		DR. SCHWETZ:  Fine.
		DR. LANGER:  All right.  Would you like to be on it, too?
		DR. DAVIS:  I think ‑‑ 
		DR. LANGER:  Terrific.  That's wonderful.  I've already got her down for something else for ‑‑ Rita, that would be terrific.  Okay, so we're set on that.  So we have a committee of four to report back to us on exactly what we could say.  I think that would be terrific.  Thank you.
		DR. LANGER:  Next, Bern wants to make a few comments as we move into the next section.
		DR. SCHWETZ:  Despite the fact that it's just before lunch, we're going to end the discussion on food safety, and we're going to move into two other examples, one before lunch and one after lunch.  But some other activities within the agency to strengthen or enhance the science base of the agency.
		The first one is a competitive intramural granting program that I wanted you to look at, and get your reaction to whether this is something that you see as operationally beneficial within the agency.
		Peggy?
Overview of the Office of Women's Health (OWH) Scientific Research Program
		DR. MILLER:  Hi.  I'm on the program as Dr. Margaret Miller, but I go by Peggy, so don't get confused by that.
		I appreciate Bern's putting us on the agenda and providing us with an opportunity to explain our program, our research program.  But really want I want is your feedback on how we can work towards improving the program.
		[Slide]
		What I'd like to do is just provide a very short overview of what our research program does, and then really open it up to some questions that we've developed to try and receive your advice on the future direction of the program so that we can modify it to ensure that we're having a maximum impact on women's health.
		And then if there's time, I would like to identify additional issues in women's health that we could bring before the Board and get your input on in the future.
		Now, the Office of Women's Health research program was established in 1994, and we had three goals at that time; and the first one was to address gaps in current knowledge.
		I want to at this point explain that when we're talking about a scientific research program, I want you to think very broadly about that.  I'm a toxicologist, and it's not 20 rats in 4 groups, 5 doses; you know, it's ‑‑.
		We look at where basic knowledge leaves off and where the regulatory decision needs to be made.  And there's usually a gap there; sometimes it's small, sometimes it's ‑‑ I'm stealing this from Steve Sundlof.  You can see, I paid attention all those years.
		DR. SUNDLOF:  That's very good, Peggy.
		DR. MILLER:  So what our research program really does is it tries to fill that gap.  What scientific questions can we answer, so that when we're making a regulatory decision the gap is not as broad as it is without the science.
		We also do some basic research, some traditional studies, encouraging new directions in the area of women's health research.  And finally, we strive to set a new standard of excellence in women's health research within FDA's regulatory mission.
		Let me just briefly run through the current funding process.  Every year representatives from the Office of Women's Health meet with the centers to identify high priority issues within the area of women's health.  We then go back and we try to focus a bit; the office takes a leadership role in eliminating some of the high priority issues and trying to focus the program a bit.
		We then send a notice out throughout the whole agency and ask for ideas or concept papers, and these would be soliciting from throughout the agency how we could design a  research study that would help us address the high priority issue.
		The office and the centers review those concept papers, we select usually between 25 and 30 percent of the concept papers to be developed into full research proposals.  
		Those research proposals are signed off through the center's management and then we send them out for a peer review, both internally and externally.  As a result of the comments of the peer reviewers and our own internal review, we fund about half of those projects every year.  
		[Slide]
		Now, the program to date is in its seventh year of funding; we've funded 86 projects, we've spent about $8 million.  In general the projects are of short duration.  We usually fund projects for one to two years, and the funding level is generally capped at about $200,000.
		[Slide]
		When you look at the program, you will see that we've just funded a wide range of topics; and that is in part because of two reasons.  One, the program is geared to fill in gaps, and there are gaps everywhere, when you look at womens health issues.  Also if you look at the impact of the agency on womens health, the agency assures the safety and efficacy of products that are used primarily or traditionally in women, and so we have funded projects on what I call traditional womens health issues.  And again these projects might be scientific research projects or they may be focus group testing, to see if people understand our labels.
		[Slide]
		But in addition to those traditional womens health issues, the agency also regulates a number of products which might affect women differently from men.  There are diseases that are more prevalent in women than they are in men.  Or the manifestation of that disease is different in women than they are in men.
		So we've also broadened the scope of the research project to cover what I'm calling these additional womens health issues.  And besides that, the agency is committed now to eliminating inequity or gender bias in studies that are designed to show safety and efficacies of clinical trials, so we have geared a lot of studies to look at gender differences and drug effects, or using postmarketing surveillance to mine adverse drug reactions to see if women are responding differently than men, doing some of the things that you can't do preclinically in the small trials.
		[Slide]
		To monitor the success of the program, we use a number of quantifiable impact measures; we look at the completion rate and our completion rate is about, of the ones that are due to be completed, we're at about 90 percent, which indicates that the program has a lot of dedication from our researchers.  We look at publications in peer reviewed journals and federal registers, other things.
		We look at outgrowths, whether the seed money that the Office of Womens Health has put into the project, has led to other projects in other areas or other activities, or whether the centers are carrying on that research in their own research programs, whether it's been integrated into their research programs.
		We have also looked to see how the program is helping to improve the science base of regulatory decisions.  So we will look at guidance documents for changes in labeling, or whether or not we've come up with a standardized analytical procedure for a laboratory for the field.  As a quantifiable measure of the impact of our program.
		However, the program also has what I call these non-quantifiable benefits, in that it raises awareness of womens health throughout the agency.  When we send out this notice throughout the agency and people see that we have grants coming and funding, it causes a lot of, "What is this?  What are you doing?  What does the office do?"  And it provides a vehicle for us to discuss womens health and the issues of womens health throughout the agency.
		It also helps to build FDA's infrastructure research.  We do do some traditional basic research funding, and that helps these laboratories supplement projects that they had ongoing by piggybacking onto an existing project.  Or we might fund a teratology study on Vitamin A just with OWH funding.
		It ensures that the regulatory perspective and the goals of the agency are integrated into the research program so that we don't go off asking questions that really are not going to be impacting FDA's regulatory decision-making.  Because we relied on the centers, with their personnel, their laboratories, their FTEs, we are able to leverage OWH funds quite effectively.  We don't have to pay overhead, we don't have to buy equipment, we can use the research dollars to get results.
		And finally, it provides for employee development.  The researcher who is sitting at the bench doing reviews day in and day out comes up with a research question.  It affords them an opportunity to do that research and get credit for it and to be enlightened by the process.
		[Slide]
		While the program has many strengths, and we certainly are very pleased with the results we have so far, we're always looking for ways to improve the program.  And one of the things we've noticed with the existing program ‑‑ the way we currently do it, where every year we go to the center and we say "What's your high priority topic in womens health?"  The program has tended to focus on urgent and important issues.  When we go to the center on a given week, on a given day, we get what issue is before them that week, that day, or last week at the most.
		So the projects that we tended to fund have been focused on the here and now, and we really haven't set aside any way of saying "Okay, this is something we want to build for the future.  This is not at our doorstep right today, but we see this as an issue out there on the horizon that's going to be coming forward for womens health, and how do we set aside some of our resources, our program to address those types of issues?"
		One idea might be to have a science advisory board much like this group, and ask them to provide what's on the horizon of womens health.  But I guess one of our first questions that we would have:  Is there a need to balance or is there a need to do more of the longer-term research out there rather than just the, what I call hot topics or the topic of the day?
		And if you felt that there was, how would you suggest that we go about figuring out what is, what should we be building for in the future?
		So that's my question to the Board.  So do I turn it over to you?
		DR. LANGER:  That's fine.  Okay, why don't we get some feedback?  Thank you.
		Yes, Owen.
		DR. FENNEMA:  Well, you touched on something I was going to ask a question about before you mentioned it; and that is that many of these research topics that you listed up there strike me as ones that if you're going to make progress on them of a significant nature, that you need in-depth research for many years, and yet you're talking about funding now for one to two years.
		And it seems to me that you need to pick out some areas where it will really be desirable, the issues of longer-term projects than what you're doing now.  And that may be where you have an advisory board to help you with this, I don't know; but I think that's going to be necessary to make the best use of your dollars.
		DR. LANGER:  Other suggestions or comments?
		DR. DAVIS:  If you look at the long list of areas you had up there, you're talking $200,000 at a pop, one of the things that Marion had mentioned when they looked at the CFSAN program was all the things they were involved in.  And I think it would be too easy to dilute one's efforts by trying to solve everything.
		There's quite a litany of areas that you put up there that the group could be involved in.  I think you'd probably get more bang for the buck if you chose a few areas to look at in depth over time than trying to go after every issue that might affect women.
		DR. MILLER:  And then if we were going to chose ‑‑ well, we'll get to that in the next slide, I think.  But there might be a role for a science advisory board to help us choose what areas are on the horizon out there in the future?
		DR. LANGER:  Ed wanted to make a comment, but I also wanted to check.  Are you not done with your presentation?
		DR. MILLER:  No; I have two more questions for you.
		DR. LANGER:  Oh, okay.  Why don't --
		DR. SCOLNICK:  The only comment, I have a hard time figuring out from what I've heard so far where what you do as part of FDA is different from NIH should be doing in womens health.
		And I think the questions you were just asked about focus and divisions of funding, because the presentation is pretty global in itself, as opposed to FDA-related.
		DR. MILLER:  One of the things, and maybe I didn't express it strongly enough, is that we only fund grants that are within FDA's regulatory mission.  So if we can get ‑‑ we have funded, cofunded research projects with NIH, so NIH is interested in it, then we will cofund with that.
		But generally what we're looking at is filling the knowledge base.  NIH will do lots of basic knowledge.  But we're looking to fund research projects that will fill that gap between where the basic research leaves off and where a regulatory decision needs to be made.
		Or we'll look at specific adverse events with drugs that are specifically within FDA's purview, are there gender differences in how women react with pharmacokinetics, can we make categories of drugs that really need enough women in a clinical trial so that we can study them.
		So these types of issues that are specifically related to FDA ‑‑ I call it practical scientific research.  They're not the basic scientific underpinning of the mechanism, necessarily; but when do we need to ask the question, how can we be smarter in asking the questions that we need to ask as regulatory people to have the sponsors address?
		DR. LANGER:  What I want to do is, maybe if you will go over the other two questions, and then we'll just get the rest of the feedback.
		[Slide]
		DR. MILLER:  Again, this gets to how do we get to how do we identify high priority issues? The landscape, I heard them talk about CFSAN having a wide scope of agenda.  If you look across the agency, between foods and devices and drugs and biologics, there's just a whole panel of products that FDA regulates that are used by women, and if we look at establishing high priority issues, even within the scope of FDA, narrowing it down to FDA, do we look at the safety of products for women?  Do we look at efficacy?  Should we be taking a step back from just looking at it from an FDA perspective and saying, "Okay, what do women get diagnosed with?  And what's likely to be coming into the agency for us to deal with as regulators, as reviewers?  Or do you look at diseases of women as a way of setting priorities?"  
		Because if a woman has a disease, we're likely to see products that are designed to prevent that disease or to treat that disease.  And if we have the underpinnings of the research program in place, will be able to make more intelligent, science-based regulatory decisions?
		[Slide]
		The last question we had is:  How shall we be looking at modifying our current process to help with leverages to address these high priority issues?  
		We have in recent years allowing an FDA investigator to contract with an academic institution so the academic institution is actually doing the study; but the researcher is an FDA-generated research question, that an FDA reviewer has identified as being needed in order for them to do their job.
		We've also done some cofunding with NIH, if FDA's regulatory mission overlaps with NIH, that we've cofunded some studies on pharmacokinetics and pharmacodynamic differences between men and women in drugs.
		So we've done a little bit of that, but I was just interested in some other ideas of how we could use these mechanisms more broadly in the future.
		DR. LANGER:  Why don't we get comments?
		DR. DOYLE:  Joe Levitt had brought up the major need in the area of dietary supplements; I think I heard that that was kind of across-the-board, the centers, and certainly there's a lot of dietary supplements that would be focused in the area of womens use, and maybe there's a good match there since that's a real high priority in the agency.
		DR. BUCHANAN:  Actually, the womens' program has been very helpful to augmenting our program in dietary supplements, and we appreciate their vote of confidence and past activity with our program, and look forward to getting a big chunk of their resources ‑‑ 
		(Laughter) 
		DR. ROSENBERG:  In a way, you already have narrowed ‑‑ to me, there is already a narrowing.  And that is, is the definition of where you fund, and that provides a pretty narrow window.  You don't want to fund things that NIH is going to fund, and you want to kind of really focus on these gap areas.
		If you kind of do that, and then you allow investigator-initiated ideas to run its course, which is the way it should be driven, as the quality of the idea as it fits that position.  It seems to me those are the two things you need in combination to make this work; it's to make sure you are defining yourself as an area of funding that's different from others, and then let the investigators decide through the right peer review committee as to what's good science to fund in that area.
		I'd keep it pretty open as long as it ‑‑ I don't have a problem with all these topics, because you've narrowed it by where your --
		DR. MILLER:  Right.
		DR. NEREM:  You may have said something and I just may have missed it; a person can get a one to two year grant.  Can they get a renewal of that grant?
		DR. MILLER:  They can submit another grant, and we will compete it with our funding, yes --
		DR. NEREM:  Does that happen, or is there a prejudice against that in the review system?
		DR. MILLER:  No, there's not a prejudice against it and it does happen.  Generally what we like to see is for our money to provide seed money and for them to be able to get other resources to carry on their projects.
		DR. NEREM:  Where would they get those other resources?
		DR. MILLER:  Either from the center itself; NCTR has other mechanisms like CRADAs.  So there's other vehicles that we can ‑‑ we like to try and ‑‑ especially in the new directions area, we like to provide seed money; and if it is a viable program, we'd like to see other groups pick it up and then use that.
		DR. NEREM:  I'm very much in tune to the seed money idea, but when there are other resources to carry on after you've been seeded; but I very much have the impression that this is a resource-limited organization.  
		DR. MILLER:  Right.
		DR. NEREM:  So are there really those resources to carry a project?
		DR. MILLER:  Well, we look at them as our outcome measures, if it's likely to lead to a labeling change, if it's likely to lead to another guidance, if it's likely to lead to some outcome measure, that's a regulatory decision-making.  And the way we've structured it thus far, those have tended to be short-term payoffs, more or less.
		And one of my questions is, should we be looking at the longer-term investment so maybe we wouldn't get a guidance out of this this year, but we build the infrastructure to help with the decision five or ten years out.  That's kind of the balance we're trying to weigh at this point.
		DR. NEREM:  I haven't looked at your program, and I don't have the knowledge to really evaluate most of the things you're doing; but it just it seems to me a one to two year timeline is just too short.
		DR. MILLER:  Too short.
		DR. LANGER:  We have lots of comments.
		Marion?
		DR. NESTLE:  In answer to the question, do you need an advisory committee?  Yes, everybody needs an advisory committee.
		(Laughter) 
		What I just heard here, though, really caught me up short because it reminded me of the same issue that we dealt with in the CFSAN review, which was, "How do the priorities get established in the agency?"  And it was the question that we asked over and over and over again.  I've just heard that you're competing with priorities, that there is some tension between how the funding ‑‑ I mean, Bob is happy to work with you because that means he gets to take resources for his initiatives, but that doesn't say what the entire agency is doing as a whole to establish priorities and how your priorities fit into the priorities of the agency.
		That's hard for us to deal with; at least it's hard for me to deal with.  I can't speak for anybody else.   So that's the same issue that comes up over and over and over again, how do you establish yours?  How do they establish theirs and how does all this get worked out in a competitive environment in which lots of other people are doing research in areas the FDA is involved in doing research.
		DR. MILLER:  When we establish ours, we meet with the centers, and we say "What are your priority issues in womens health that you're dealing with this year, in this fiscal year?"  Usually we just do it on an annual basis.
		So if they're working on dietary supplements and dietary supplements is a big issue for them, then we'll say "Okay, what dietary supplements are used in women, where is the overlap between dietary supplements and womens health?" that the agency can impact.
		That's the other piece.  Where if I do this research, it's going to result in something the agency can use --
		DR. NESTLE:  And nobody else is doing.
		DR. MILLER:  And nobody else is doing.
		So that's how our program integrates it to the centers, under the current process.  And I said, the only downside to that that I see is that we tend to deal with issues that are urgent; this is the high priority, you know; we don't deal with long-term chronic illnesses because those are knocking on our door today.
		DR. LANGER:  Bob, did you want to--?
		DR. BUCHANAN:  I just wanted to offer one point of clarification for you, Marion. 
		While they help fund some of our research supplement it so that we get in areas we don't normally go in or wouldn't have the resources, they do not pay the salaries of our PIs in conjunction with these; these are supplemental funds.

		So we have a great deal of interest if they're going in to proposing areas that are not within our priorities, that we're involved in that priority-setting process.  And it does take place, we sit down, we talk about what our priorities are in terms of our programs, they talk about what their priorities are, we sort of come to an agreement on what are the areas that match the priorities of both programs.  And those are the ones that wind up surfacing, and we request additional ideas from the scientist on the staff.
		But it's not totally bottom-up driven.  There is a decision because we are ‑‑ it's the resources coming from our research program that actually pays a big chunk of this program.
		DR. LANGER:  Dr. Anders.
		DR. ANDERS:  I have had some familiarity with this program in my relationship with NCTR, and have always viewed it as something of a pilot project program.  And I think Joell James' work on folate and Down's syndrome is a classic example of how OWH funding allowed her to get preliminary data by reaching to an NIH grant.
		My question is, one way to judge on the success of a pilot project program is how many of these pilot projects went on to funding by NIH or the agency or whatever.  Do you have any information about that?
		DR. MILLER:  We capture that under outgrowths.  I have statistics; I didn't bring them today, of how many projects have gotten picked up by other people that have spawned other research.  We fund that under the outgrowth.  We do monitor that as a quantifiable.
		A little bit, we have a little problem with boundaries, like the dietary supplements.  If I funded one piece of a small project five years ago, do I still claim credit?  I think the folate example is a good example of where we had outgrowth.  The effective drugs on cardiovascular disease is one where we've had a lot of outgrowth as a result of a little bit of seed money that was put in.
		So we monitor those as outgrowth of projects.  But as I said, I'm not sure how long we can keep on claiming credit for some very good work that she keeps doing in other areas.
		DR. DAVIS:  I guess what I'm wrestling with is, what do you all perceive as your mission.  Because I'm hearing where you think we ought to be going, and as I look at the brochure in our booklet, one of the sentences that jump out, it says that: 
	It utilizes a competitive peer review process for selection of the highest quality project with an emphasis on projects with the greatest potential for significantly contributing to knowledge of womens health in a brief period of time.
		So to me if you start looking for, where is this going to lead downstream or what's the outgrowth, it sounded like when you first started that you have a defined problem that has specific interest to FDA, and so how do you solve that problem?  What's the answer to that in terms of labeling or regulatory decision-making?
		It is so easy I think to drift off into basic science if you're not careful when you start putting up this long litany.  And you say "Well, NIH does basic science."  But I think all of us who know anything about NIH know they're doing all kinds of stuff; clinical stuff, basic science; that they don't limit themselves to just basic science, because it becomes nebulous how you define basic science versus clinical science a lot of times.
		So I think you're going to use up your funding and your resources if you don't have a mission that is clear and then stick to it, especially in the short term.  I personally like the avenue of, how is this going to provide FDA something they can specifically use to make regulatory calls?  And I think that's the work of FDA.  Anything other than that, trying to understand diseases or, if you ask yourself what diseases are out there, they'll likely come to us, to me that starts to smack of not regulating issues but trying to get ready for something that might come that may or may not come.
		DR. MILLER:  So I guess if I ‑‑ what I hear you saying is, whether it's long-term or short-term, as long as we keep that goal is, how is the FDA going to be able to use this information to improve womens health, which is what our goal is, then we'll be fine; that that focus, as long as we keep that shining.
		DR. SCOLNICK:  Is it to improve womens health or is it to improve your ability to make regulatory decisions?
		DR. MILLER:  That impact on womens health.
		DR. NESTLE:  Exactly.
		DR. SCOLNICK:  Yes.  I mean, to improve womens health is an NIH function, not an FDA function.  
		What is your peer review process?  I would just echo what Harold said.  I really have a distinct sense from listening to you that the lines are really blurred.
		What is your peer review process for these grants?
		DR. MILLER:  We have internal peer reviewers as well as, we ask the principal investigator to identify three external reviewers that are knowledgeable in the field; and then we contact them, ask them conflict of interest questions, ask them if they would agree to review the project.  Then the office staff sits down with the internal reviews and the external reviews to put together the final portfolio.
		DR. NEREM:  Sort of like asking the president to give three names of people to write letters of recommendation for ‑‑ 
		(Laughter) 
		DR. MILLER:  Well, unfortunately with the diversity of projects that we have before us, we also asked internal reviewers; and if we feel that there's other people in the area.  So we have a database now of reviewers much like NIH does, that we can tap into on certain projects that have been good objectives.
		DR. LANGER:  Any other questions?
		Yes.
		DR. NEREM:  Just one thing since you brought it up, you know the possibility of something like this ending up with NIH funding, was that an --
		DR. MILLER:   A real life example.?
		DR. NEREM:  Was that an FDA person?
		DR. ANDERS:  NCTR staff person.
		DR. NEREM:  I guess my bias about NIH would suggest that the kind of things that NIH would ultimately be interested in in fact would not be the kind of things that we're talking about, maybe this program ought to be targeted.
		DR. SCOLNICK:  Well, no, it's ‑‑ it's too short a time to understand it all, but I'm not convinced of that at all.  I mean, if you talk about issues of pharmacokinetics and drug metabolism, things like that, there's so much basic science going on in that world outside of the FDA that ‑‑ I'm not at all convinced that that's not already going on; all the FDA has to do is take advantage of that body of information and what they have to fund separately.
		DR. NEREM:  Oh, I agree.
		DR. SCOLNICK:  So I don't really have a good sense for the distinctions here and what really should the FDA's purview -- I can tell you that I echo Harold's comments.
		DR. MILLER:  Right, but we'll look at that, we'll look at this, how is this going to impact our regulatory decision-making processes.  How will this influence our label-writing, how will this influence our ‑‑?
		DR. NEREM:  I would be more interested in that than I would be whether it had the potential for NIH funding.
		DR. MILLER:  But as you notice, I've had three goals, and one was fill gaps.  The second was new directions; and actually Jill James fell under new directions of research.  That was something we would put a little bit of money in, see if it leads anywhere, has a potential.
		DR. SCOLNICK:  It really relates to what Marty Rosenberg said.  If you're going to be funding research into womens health without the kind of infrastructure of peer review with investigator-initiated best ideas for womens health that NIH has, then I think it's really like it's a very different process.  And it really needs to be scrutinized.
		DR. LANGER:  Let me, as we close the session, make two comments that might be good to go over at a future session that I heard.
		One is to try to put together some statements that make, I guess the lines less blurry.  And the second I think this issue of peer review; I agree.  I'm concerned that when I hear this, Bob's comment about asking your friend ‑‑ in other words, the question is how do you maximize this objectivity?  And I think that maybe needs to be given some thought.
		So what I might suggest is if you at a future meeting, those two issues I think highlight a number of important points that people make.
		DR. MILLER:  So how do we focus in on FDA issues only.
		DR. LANGER:  Well, I don't think it has to be worded like that.  I think --
		DR. NEREM:  On FDA's needs.
		DR. MILLER:  On FDA's needs.
		DR. LANGER:  Yes.  And the second thing is, I think a greater way of ensuring peer review and objectivity ‑‑ I mean really his point about, you know, how do we really make sure you get the best things done? 
		DR. MILLER:  Great.  Thank you very much for your attention.
		DR. LANGER:  Thank you.
		So what we'll do now is I guess we'll take a lunch break, and I'd like to meet back at 1.  And we can do some more work over lunch.
	[Whereupon, at 12:20 p.m., the meeting recessed for lunch.]

	A F T E R N O O N   S E S S I O N
	[1:08 p.m.]
	Joint FDA and Industry Training
		DR. SCHWETZ:  This example is an effort that involves training and outreach.  One of the things that we struggle with as an agency is the rapid pace of changing technology, and this example of training programs that actually take place out with the industry, joint meetings between the industry and FDA scientists and others, is meant to move us up on the learning curve faster, so that we learn about technology before the submission actually comes to us, and we maximize the interaction between us and industry early on.
		Susan?
		[Slide]
		DR. FITZPATRICK:  As we heard earlier today, one of Dr. Henney's chief initiatives is to increase the science base at FDA.  So she asked us to begin this project about ten months ago to look at joint FDA-Industry technology training as one way of not only leveraging our resources but helping to increase the science base at FDA.
		[Slide]
		The specific objectives of this training were, as most people ‑‑ this is for our review scientists that are reviewing the petitions that are coming in from the industry or our field investigators that are out in the field, actually going on inspections.
		They need a way or a mechanism of staying up to date with the fast-paced change in technology, and recognizing that most of the technology that we ‑‑ new technologies that we deal with are developed in industry rather than in some other setting.
		We decided to try to see if we could set up a program that would have the industry help us train our FDA review scientists and field investigators in some of the new technologies before they see those technologies in some type of petition or in a field inspection setting.
		So the specific objectives were to have the industry talked about the technologies.  For FDA to talk in general terms about what types, for those technologies, what types of assurances they would need to make sure it was well-controlled and adequately validated.  And also, we thought this would be a good way for FDA scientists and lab analysts, field investigators and the industry scientists to be able to discuss technologies, the technology and the science apart from the regulatory arena. 
		[Slide]
		Most of the time when we're dealing in meetings with industry, it's probably over a regulated product.  Those aren't always the most collegial meetings, and this was a way to be able to talk about science without the regulatory aspects of a particular product.
		[Slide]
		I think one of the important things that we envisioned in this program was, we wouldn't just be talking about it; we would be going out and actually observing it.  And when I talk about the specific courses that we've done, I think it will become a little bit more apparent.
		Now only do we have people talk to us about the technologies, but we've actually gone to the laboratories or the manufacturing facilities of the industry and viewed the technology firsthand and had a chance to really talk to their scientists, but questions that come up as we actually view what's going on.
		[Slide] 
		Our anticipated outcomes in this type of training, we thought, you know to give our scientists and our field investigators a more in-depth knowledge of the technology may help facilitate more expedient scientific reviews and more expedient field inspections.  A lot of what goes on in the review process is back and forth, trying to understand what's in a submission; and if we can give our scientists a heads up on some of the new things that are coming in, that might make the whole process more timely.  And in addition, it might help these technologies enter the marketplace sooner.
		I think the other thing that's important is that FDA and industry will gain new perspectives on each other's concerns, especially in the area of new technologies.
		[Slide]
		We just started this program last June and we had several training mechanisms that we used to implement the program.  The first was because originally this program focused on the field investigators, and then we brought the center scientists into it, we had to choose ‑‑ we chose the topics and new technologies based  upon a technology interest survey that we did of our senior field investigators.
		We went out to all the district offices as well as headquarters and asked our senior investigators what technologies they thought that they might need training on.  We wanted the training to cover a wide variety of scientific issues in the different centers and we wanted the training to take place in different geographical regions of the country.
		And of course we needed some way of making an agreement with industry in order to be able to do this type of training, which was a new endeavor, a new way of thinking for the Food and Drug Administration.  So we used what's called a cosponsorship agreement as a mechanism for developing or making an agreement with industry to do joint training; and in that agreement we talk about the responsibilities of FDA, we talk about industry responsibilities.  There's no money that exchanges hands between the two parties.
		We make a specific point that we're talking about science, and we're not talking about specific regulated products.  In other words, if we go in from the industry, this isn't sort of their way of having a private meeting with the FDA to discuss products that they might have pending; we really want to keep it to the science.  I must say that the industry has been really wonderful about just keeping to the scientific issues.
		We have our cosponsorship agreement looked at by our ethics department as well as our general counsel, and of course the industry has their lawyers look at it; and the information that they give us, the confidential information that they give us is treated as if it was a submission given to the FDA under any other circumstances; it's not public knowledge, it's kept confidential; we're bound by 2061 which is our confidential and trade secret agreement.  That binds us in these courses and in any material that they might give to us.
		We have been putting that into the cosponsorship agreement so that it's made clear that if they're talking about confidential things, that they're not going to have to worry about those getting out to the public.
		And for our own sake, so to speak, we also, in addition to making a cosponsorship agreement, we look at the regulatory history of the place that we're going to train.  If we're in the middle of a regulatory disagreement, so to speak, with that firm we probably wouldn't go there to train on some new technology at this point.  So that's an additional safeguard that we look at when we're developing these programs.
		[Slide]
		Our first course took place last September, and it was cosponsored by the Food and Drug Administration and Merck.  And it took place September 29th in West Point, Pennsylvania.
		One of the things that a lot of our field investigators wanted to find out was about the new technique of barrier isolation technology.  It's a new sterilization technology, and we knew that Merck had a new, state of the art barrier isolator that was just coming on line in their West Point facility. 
		So we jointly put together the agenda with the Merck scientists, with the Office of Science, the CDER, CBER and CVM sterilization experts; these were our senior scientists put the agenda together with our senior ORA field investigators, and we went up there on September 29th.  
		Not only did we listen to them talk about the scientific aspects of the barrier isolator, we talked about our validation concerns; but we actually spent three hours in the barrier isolator itself, and I don't think that there's anything that you can do ‑‑ not inside.  But in the room ‑‑ you have to really see it; it's a $40 million piece of equipment that takes three or four rooms, and 600 vials go through in a minute, and I think by actually seeing this type of technology stimulates a lot more questions in your mind if you're an investigator or if you're a scientist reviewing the nationally ‑‑ reading about it on the paper.  
		They actually got to see it and we had an interactive-type session; and then after that we came back, we talked about, some more questions.  One thing that we did prior to having this course is that we exchanged a list of questions.  Merck gave us some questions that they were interested in having us answer, and FDA, the different parts of the FDA that attended the course gave Merck some questions that they like covered as sort of a starting point.  
		If anyone has been to an FDA meeting, and you comment and hit people cold, it's often not the best way to get answers from the FDA.  So this was one way of exchanging questions in advance that we'll be able to know and think about what we wanted them to talk about. 
		So I think that was very successful.  We took about 25 FDA people up there, then we had a lot of industry people go, too; and I must say Merck was really wonderful in hosting this activity.
		[Slide] 
		Our next course that happened this past January was how the application of ELISA rapid screening methods to the FDA field investigations.  Now, ELISA rapid screening methods probably doesn't look like a new technology to anybody here, but it is a new technology in FDA field investigations.  And this course was cosponsored by the FDA, the National Center for Food Safety and Technology, which is our Moffett Center; and the Grocery Manufacturers of America, and it took place in Minneapolis, Minnesota and General Mills.  Our participants were CFSAN and CVM scientists from headquarters, the ORA headquarters and field investigators include several of our import investigators.
		We had the NIST scientists and we had the Minnesota Department of Agriculture scientists also attended the course, and really what it was was not only did we learn about the theory of ELISA rapid screening methods, or they talked to the investigators about it; but we actually went into the General Mills labs ‑‑ they ran them themselves.  
		They ran microbiological assays and they ran chemical assays, and they got a chance to interact with some of the General Mills and the Pillsbury scientists about the pros and cons and pitfalls and questions, and got a good sense of what, if they had to either evaluate these out in the field or use them out in the field, what kinds of things that they would run into that ‑‑ that you might not get from just reading about it on a paper.  Anyone that has tried to duplicate someone else's technique has to almost go into that lab and learn it, because they don't write down all the little nuances that you need to be able to do some of these things successfully, without going over and over and over again.
		[Slide]
		Our next course is coming up in a couple of weeks.  This is a course on Microarray Technology.  It's cosponsored by FDA and the Bay Area Bioscience Center.  It's May 16 through 18 in the year 2000, and it's going to take place in San Francisco, California. 
		The Bay Area Bioscience Center is a biotech association located in the San Francisco Bay Area.  They have pulled in ‑‑ and with it, we have ‑‑ what's more, Dr. Schwetz, who comes to all of these and actually, there's great support and it's really appreciated.  I think by all of our field folks and scientists for endorsing this type of training and showing the importance of it.
		But we have our, some of our people that are really knowledgeable in the area of microarray technology, from CDER, CBER, CDRH and NCTR attending, as well as our San Francisco and San Diego field compliance officers and investigators.
		And the course agenda, it looks really interesting.  It's going to take place the first day at Stanford.  We have five different companies from the San Francisco area that are to present their technology.  We're going to have three companies that are not developers of microwave technology, but they're users of the technology talk about what they've seen, and then the next day, we're going to ‑‑ two of the developers of the company; I think it's Heisic and Insite (ph), to look at their actual microarray systems and talk to them about quality control issues.
		Then we're going to go to Roche, who is an end user, and look at the way they're using these technologies, their applications of it; and then the following day we're going to go to Afametrics (ph), because they just built a new manufacturing facility and we want to view that and really talk about quality control issues, but talk about them with just that one firm so that they can feel a little more free to talk about those issues.
		In addition, NCTR is going to present to San Francisco some of the research that we're doing in the microarrays.  
		[Slide] 
		So I think this is going to be a really exciting course; and then the following week, May 22nd, we have a course on Nucleic Acid Amplification testing.  This is a new way of screening blood that many of our field investigators as well as our center scientists wanted to learn more about.
		Before, it's actually required in all of our blood banks.  And we're cosponsoring this with these five companies which are actually developers of the technology.  They're not the ones that are going to be doing the screening in the blood banks, but they have developed ‑‑ four of them have developed different NAT testing procedures and instrumentation; and that's Gene Probe, Roche Molecular, Chiron/Bayer Diagnostics, Organon Teknika, and then the National Genetics Lab actually has not developed the technology, but it has ‑‑ it uses a lot to be doing screening, samples are sent in and they screen them.
		So they are actually, they're going to be here in Rockville for May 22-25, and each of these four companies are bringing in their instrumentation and their technology and they're setting them up in one of the CBER labs, and all of the labs are ‑‑ we're providing four different laboratories; they're all secure facilities so that we're treating their instrumentation and technology as if we would treat a submission; we're to our best effort making it as confidential as possible.
		One of these companies, I can't remember which one, has some giant robots they might be bringing in, too, as part of their system; so that will be interesting to see.  The participants are, once more Dr. Schwetz, and we have CBER and CDRH scientists and our national blood experts are going to be coming to this course.
		CBER and CDRH, the scientists who are actually doing the reviews, are going to be talking to each other about their different perspectives on this technology, because one thing that we've learned in this endeavor, we've picked topics that are sort of crosscutting; they affect more than one center.  And it's a way of, and a stimulus for our different -- center scientists from our different centers, to actually be talking about and sort of agreeing on common approaches to these ‑‑ and common thoughts and perspectives on new technologies.
		So they'll be talking to our field investigators; then we're breaking them down into groups of eight or nine, and they'll spend a half a day at each one of these laboratories.
		Actually, I don't know if running or seeing run or actually viewing firsthand all the different ways to do the NAA testing in anticipation of actually having to either go and be an investigator in a blood bank, looking at the technology; or in anticipation of having to review this technology.
		[Slide]
		And the last course that we're working on for this year is called, New Trends in Sterilization Technology.  And this is going to be cosponsored by the FDA and Johnson & Johnson, and it's scheduled right now for September 5th through 8th of this year, and it's going to take place in New Brunswick, New Jersey.
		The course -- we're going to take up to New Brunswick are probably, our senior sterilization experts from CDRH, CVM, CDER and CBER and our ORA field investigators.  But we are also going to try to broadcast the lecture part of the series out to our district offices, and then we're going to go to the different labs, either Johnson & Johnson or some of their other manufacturing people in the New Brunswick area and actually view some of these new technologies in the laboratories and have a chance to talk to them about it.  That part, I don't think that we're going to film because I don't know technically.  If we can, we may.  If we can't, we can't.
		But then we're going to follow up with a lecture series for more of the beginning reviewer on just general principles of sterilization.  We're going to try something where we broadcast it; the person may be there in one of our ‑‑ here in the headquarters, but we're also going to try to broadcast that to the district and maybe have that as a follow-up every week for a few months after that.
		[Slide]
		That's really what we put together in last ten months.  I might say that this program has been met with just very positive enthusiasm, not only from all of the centers have given us great support in running this program, been really cooperative in developing the agenda and helping us design the courses.  But I think it's been met with very positive enthusiasm from the industry.  I think Dr. Henney has been really applauded for her foresight in being willing to support something like this; and we're hoping that we'll be able to continue it in the following years.
		We feel like, for one thing we've been able to train a lot of scientists.  Really, the cost to FDA is getting our scientists there.  And I know for example on the barrier isolater course, I saw an announcement for one of the trade associations giving a course.  It was an all-theoretical, it had a very hefty price tag, and I don't think you can match what Merck did for us in actually letting us go in and viewing the instrumentation right up front.
		That was just so much more valuable than sitting there and listening to it for two days, about the theory of it; actually seeing it and watching it run and stop, and seeing all the things you might have to think about if you were trying to decide if it was actually doing what it was supposed to do.
		So in anticipation of additional funding for our program next year ‑‑ and it's nice to see Dr. Suydam here listening to this as we talk about that part of it ‑‑ I have a couple questions for the Science Board.
		[Slide]
		One of the questions that we're talking about is what were the other mechanisms to select new topics or technologies for this program?  I told you earlier that we did a survey of our senior field investigators, because that was the emphasis at first with Dr. Henney, was to get our field investigators really competent in all these new technologies are on board.
		And actually, we have expected our field investigators to have the same level of scientific rigor in taking these courses as are center scientists.
		What would be other ways ‑‑ because not every technology we're going to find from the field and if we continue, we want to have maybe less of an ad hoc way of selecting topics.  
		Then, what recommendations do you have for improving the program?  Every time I give one of these courses, I try to analyze what I can do better on the next one.  What ways can I get people to talk more, can I get people to interact more.  What are some follow-up activities that might come of the training instead of having just a one-time deal.  For example, for our ELISA test, the investigator said "Maybe we can have a checklist to go in to, when we go in to, on an inspection, a checklist of what we should be thinking about if we're evaluating this kind of study."  And that's one of the reasons we've had this follow-up lecture series on sterilization.
		How can we train all of our scientists and have as broad an impact as possible?  And work with industry on that type of program.
		So with that, I'll turn it over to the Science Board and the audience for questions.
		DR. LANGER:  So, comments or answers to the questions?
		DR. DAVIS:  One point.  When it says that industry scientists were present, like at the merck one and also the General Mills, does that mean people, scientists outside of Merck got invited, or just Merck people?  What does that mean.
		DR. FITZPATRICK:  At the Merck facility, only Merck scientists were there.
		DR. DAVIS:  Okay.
		DR. FITZPATRICK:  Because of the location and because of the ‑‑.  But we felt that we weren't really giving an undue advantage to Merck because by training our scientists in this technology, we're really 
anybody, any manufacturer who's bringing this technology in to the FDA.  Because they'll all benefit for a reviewer or a field investigator that really understands the technology better.
		DR. DAVIS:  No argument; I just wasn't sure --

		DR. FITZPATRICK:   But at General Mills, there were scientists from about nine companies.
		DR. DAVIS:  The reason I asked that--
		DR. FITZPATRICK:  There was Hormel and Frito and Pillsbury --
		DR. DAVIS:  The reason I asked is the ‑‑ that's in the Bay Area?
		DR. FITZPATRICK:  Yes.
		DR. DAVIS:  ‑‑ I'm assuming, because that's a host of companies ‑‑ 
		DR. FITZPATRICK:  Right.
		DR. DAVIS:  ‑‑ but there will be a host of companies represented.
		DR. FITZPATRICK:  Right.
		DR. DAVIS:  And actually, we went on the web at my company just the other day under Biocom to see if we could find something out about the meeting.  And there was nothing there.
		And that's why I was a little confused whether that was going to be open or not open, or ‑‑ do you know what --
		DR. FITZPATRICK:  Well, they're not generally open to the public.  They're not public meetings and we don't ‑‑ they're really training sessions. We haven't done a Federal Register notice or anything like that, opening it up to ‑‑ because we're dealing with people's scientific ‑‑ it will be open, I think, for those firms that are interested going through -- we've left it up to the Bay Area Bioscience Center, as we left it up to Merck, to decide whether they ‑‑ who was going to represent them at the industry.
		DR. DAVIS:  So it's not unusual to you that it's not on your web page?
		DR. FITZPATRICK:  No.  No.
		DR. ANDERS:  I think Ed provided a partial answer to new topics in your comment this morning when you're evaluating staff; what's the most exciting new findings or new technologies in the field?  And that can certainly be, guide you in selecting topics for this program.
		DR. LANGER:  Yes.
		DR. ROSENBERG:  One way you may do that is through Pharmala or Bio.  You can use the trade associations; that way you can get access to all the pharmaceutical companies.  I'm sure there might be things that, each of the companies that would be of interest to you.  Those kinds of things.
		The other comment, though, is also that ‑‑ make sure that for some of these things, for example what you're doing now with array technology, that's such a new technology, and not yet firmly established.  You're going to have to make sure that you reassess as you go along that you don't kind of do this as a one-off and think you know or understand the technology.  I think there's an incredible amount of development.
		And my sense, and I'm just getting into my own personal opinion, is that when you get four biotech companies, you'll get four info-commercials about their technology.  And therefore, you'll need to follow up with end users even moreso on a new emerging technology to make sure that you're really seeing the problems, the caveats, the upsides and downsides of these technologies, and so on and so forth.  So that was just a general comment about circumstances.
		DR. LANGER:  Good point.
		DR. FITZPATRICK:  I almost sound like a broken record when I'm in these planning meetings because I say continuously, "Now we really don't want a commercial on your product.  You know, we're talking about science and technology there, and I understand that any company that comes before a large body of FDA may want the tendency to do it," but we kind of build that into our cosponsorship agreement.  That we're not talking about your products --
		DR. ROSENBERG:  No, it isn't that; it's just that any scientist will always present the positive side, and tends to limit some of the negatives and caveats, particularly if it's their technology.  And it's sometimes the end user who is trying to use it, who figures out all the problems with it.
		It seems to me some of the things  you're looking at are more established technology, some of them are earlier technology.
		DR. FITZPATRICK:  Yes.  And we did ask that we didn't want any presentations on the microarray systems from any company that's more than a year away from having a product, an end product.
		But we do have three end users on that are going to talk to us about how they view EoS - Roche and one other; they're going to be talking about ‑‑ they've used a lot of the different microarray systems.
		DR. LANGER:  Michael and then --
		DR. DOYLE:  Marty just addressed my point.
		DR. LANGER:  Okay.  Harold?
		DR. DAVIS:  I think that as an end user myself, one of the things that concerns us in industry, if I can speak somewhat more globally, is that when FDA sees these new techniques, they get convinced that they are ready to be applied.  And then the question comes back to us when we're standing there with a dossier is "Why don't you use this technique to answer a question" et cetera, because these new biotech companies will convince you that this is ready, that it's validated and it will answer all the questions.
		We are fearful that we will run up against the FDA, saying "Well, why didn't you do X, or you need to do Y."  So I think one has to be careful that every new thing that comes down the pike will, over time, prove to be a very useful tool, doesn't become a regulated tool necessarily so quickly.
		DR. SCOLNICK:  I also think you ought to reach out to universities for this program.
		DR. FITZPATRICK:  The problem with going to universities is that under the cosponsorship -- and actually, they are going to have some university scientists speaking from Stanford at this.  The FDA cannot pay for university people under the cosponsorship agreement mechanism.
		The only thing we can pay for is FDA employees traveling to that facility.  We   can't even pay for a special government employee coming to that.
		DR. SCOLNICK:  No, but I know --
		DR. FITZPATRICK:  So the industry has to be willing to fund that.
		DR. SCOLNICK:  But you can try to gather information from the leading science departments in the leading universities as to what technologies they think are interesting, and then go to someplace like Pharma and try to get them to sponsor it.
		DR. FITZPATRICK:  Right.
		DR. SCOLNICK:  The course, what visits -- you know.  Because all this stuff starts in a university somewhere.  
		DR. FITZPATRICK:  Right.
		DR. SCOLNICK:  And it's just keeping you up.
		DR. LANGER:  And the FDA can have courses here.  I remember doing that myself a number of years ago in drug delivery.   So I think that Ed's point is good; you know, you could probably expand it ‑‑ bring people here.  It's not the same thing as seeing it; it's just a complimentary.
		Other comments or questions?
		Okay.  Well, thank you.
		Now we have a session for open public comment.  Are there any people from the public that would like to speak?
		[No response.] 
		DR. LANGER:  Okay, that's I think what we anticipated.
		So now I'm going to turn this over to Bern for really essentially the rest of the meeting, whereof he's going to lead a discussion on strategies for maintaining quality of science at the FDA.
Strategies for Maintaining Quality of Science at FDA
		DR. SCHWETZ:  One of those measures that we have been working on to help to strengthen our science base to reach out and gain access to people who could help us with mechanisms other than hiring them, this whole topic of leveraging and how we manage that, what the directions are.
		Linda Suydam has provided leadership and focus on this, as you've all in the last couple of years, and Linda is going to lead us through some thoughts on where it is currently.
		Linda is the Senior Associate Commissioner.
	Leveraging Resources
		DR. SUYDAM:  Thank you.  I am very pleased to have this opportunity to talk to you about leveraging, one of our major priorities in terms of mechanisms for being able to get FDA's job done.  
		There are a couple of points that I'd like to make about why leveraging, what is leveraging, why now, and what we're hoping to accomplish.
		Let me start out by saying that the FDA budget at the present time is clearly not enough to meet all of the competing needs that we have for our resources.  And the other limiting factor on that budget is that about 70 percent of it is tied up in salaries and benefits for the people in the organization.
		So we have very limited resources to go outside of the agency to do things, but we felt very strongly that we needed to focus more on, how can we expand with others mechanisms of getting our job done?
		So we took on a leveraging initiative. Starting last fall I chaired a working group that was across the agency, and I think we've had tremendous successes.  Now leveraging is not new, leveraging is something that we've been doing for a long time; but what we're doing is changing the emphasis.
		So let me start by saying what is leveraging?  Leveraging is the creation of relationships and/or formal agreements with others outside of the FDA that will ultimately enhance our ability to be able to meet and to do our public health mission.
		Leveraging amplifies that public health impact, it emphasizes a proven way of doing business.  We have a number of successes in this area, including our Moffett Center out in Chicago, and a number of programs like our Take Time to Care, Use Medicines Wisely program that was operated out of our Office of Womens Health.
		It also capitalizes on existing assets that we have, both intellectual and structural, and it values the capability of others in supporting our common goals.  And we want it to be a primary strategy.
		I think one of the reasons that FDA has not focused on this is that we've tended to be in the past a relatively insular agency that has believed that we can do it all.  And unfortunately, we can't do it all, and that doesn't say that people aren't doing their jobs or they're not doing their ‑‑ they're giving 120 percent.  It just means that in order to be most effective we have to use resources that are outside of the agency.
		And why now?  Well, it's very clear to us that the expertise and ideas and solutions no longer reside in either one person, one organization, or at any moment in time.  We think that the value of what we do is determined to a greater extent by the stakeholders to go outside of the agency and the FDA Modernization Act of 1997 actually called for it; it said consult with outside experts.
		We also believe that effective responses to public health threats require an involvement of a diverse group of key players.  So we can't do it within FDA alone.
		Then finally, science, technology, global economics and communicating information and public expectations for safety all demand a leveraging type of professional alliance.
		As I mentioned, we have a number of examples of very successful leveraging projects.  The Moffett Center, which was established more than ten years ago in Chicago in order to look at the safety of food technology.  The Mammography Quality Assistance Program which is run out of our Center for Devices is another good example of how you can use FDA resources to get things done through other bodies.
		Recently we've established our Product  Quality Research Institute within the Center for Drug Evaluation and Research, which is a consortium of lots of people outside through the American Association of Pharmaceutical Scientists, who are putting money into a centralized project.  And that project with its Board of Directors then decides which projects are going to be funded for research that is common to all of the people in the pharmaceutical industry.
		Our Joint Institute for Food Safety and Applied Nutrition at the University of Maryland is another example; and I mentioned briefly our Take Time to Care, Use Medicines Wisely program, which is run out of our Office of Womens Health, which has been an incredibly successful program using the National Association of Chain Drug Stores to distribute the materials that we developed, and to use a variety of other organizations to partner with us to get the messages out.
		In doing this, we're really talking about changing a culture at FDA; and when you change a culture, you need to provide people with the tools that they need to change that culture; and as a result we have put together a whole variety of mechanisms that we think will be helpful to people in the future.
		So we've developed a leveraging action plan, we worked on the priorities in that action plan.  We developed a vision statement and guiding principles.  We have a leveraging handbook, which is available for all FDA employees on line.  We have an FDA Internet website.  We have a compendium of leveraging examples.
		We've recently held two stakeholder engagement meetings on leveraging, one out at Stanford at the end of March and one at Duke, just last week ‑‑ I think it was just last week; it seems like it.  It must have been last week.
		Both of those were incredibly successful meetings in terms of people coming forward with ideas about how FDA can work with a variety of partners to help get our public health mission completed.  
		Then in addition to that, we're building the infrastructure within the agency so that we have center contacts, we have a leveraging task force group that will be working as a consultant panel; so that if you have a leveraging idea as an agency employee, you go to the consultant panel and they will give you advice on how in fact you can get that done.
		Then we're finally building leveraging into our performance plans, both individual and organizational, and also building it into our budget.
		I think the handout you have shows a couple of different figures of how FDA's supports are leveraging initiatives, and we really believe that the circle of innovation that we're trying to accomplish can start either with FDA scientists, it can start with people outside.  It can start with any of our partners, professional organizations, universities, industry, consultants, consumer groups, state, local or federal government, are all partners and people that we can work with to leverage the resources we have.
		I think we're very enthusiastic about this project, and we really are hoping that it will help to build relationships and also expand the intellectual capital that's available to the FDA in order to get our job done.  And leadership is needed because right now sometimes the ideas are ill-defined.  Our partners are also not always very organized.  The power and resources may not be even and so we have to have the kind of principles that we have.  Problems can be scientifically or technologically complex.  Sometimes different perspectives can also breed adversity, but we think we can work through all of these things.
		So we think that leveraging can be a variety of things, and want people to know that.  It can be formal or informal, it can have short-term results or long-term results, it can be a project where we have high control or where we have little or no control, a project where we have great oversight or where we have little oversight; it can be a project where we work with one organization or with many organizations.  It can be a project where we're working with partners that we've known for a long time that we've worked with in the past like our state counterparts within all of the state governments, or it can be a project that will be with new partners, people that we have not yet worked with.
		And then it can also be something that is a proven approach somewhere where we already have a model in place, or it can be a totally innovative effort.  And I think the project that Suzy talked about just previous to this presentation certainly points out that this is a way FDA is in fact leveraging its resources, by using these types of training programs that we're working with industry on. 
		We've asked our senior staff to be incredibly supportive of this program; we've asked them to be champions for it; we've asked them to help build the infrastructure; to promote it as an option early on.  So not to think when they're presenting new ideas or new programs that it means we need more people to get the job done.  It's a project that we want them to think of, how can we leverage resources by taking some dollars and applying it outside the organization?
		We expect our senior staff to monitor and track progress at the projects, to reward and recognize efforts and to report the progress periodically to the commissioner.
		So at the Science Forum last year, Dr. Henney said "We leverage so that we can bring a wider range of scientific thinking to bear on public health issues.  It's a smart way for us to do our business."  And I think that's the message we're trying to get across about this project.
		I'll be happy to take any of your questions.
		DR. DAVIS:  In the material in the book, and several times mentioned this morning, you mentioned Moffett.
		DR. SUYDAM:  Yes.
		DR. DAVIS:  And also there is JIFSAN, two different leveraging programs.  Is it the same thing just on different places, or two totally different programs?  Could you explain the difference, if they are different?
		DR. SUYDAM:  I think I can explain, the initial Moffett Center was started out in Chicago in 1989, and it was focused on, primarily on food packaging, as I understand it, you know?  And processing.  Packaging and processing.
		JIFSAN's focus is much broader in terms of food safety, and I think those are the differences, although Bern may have a better--
		DR. DAVIS:  So is Moffett still in processing and packaging, or has it broadened itself?
		DR. SUYDAM:  No.
		DR. SCHWETZ:  But they're also, I gave the example this morning of, the research that's going on there to figure out how to do a pasteurization of products without destroying them; cold pasteurization, other ‑‑ there may be other people in CFSAN who could say a lot.
		DR. SCHWETZ:  Sam, you can help me.
		Work of that kind that has a direct problem associated with it for health, that we know there is a problem with contaminated juices; and the work can go on there to try to figure out exactly how to do it; the work that Joe mentioned on sprouts, to make sprouts safer.
		Sam Page is the director of JIFSAN.
		DR. PAGE:  I think another major difference is that JIFSAN is a virtual organization.  We have a very limited amount of staff involvement with a liaison between FDA and the University of Maryland and private sector.  Whereas there's actually a major branch of the Food and Drug Administration that is part of the Moffett Center in Chicago, in our Office of Plant and Dairy Foods and Beverages.
		The other part of that in fact that JIFSAN is one of the major if not the major initiative is in the integration of FDA research components with the university.  We have a new building under construction at College Park adjacent to the University of Maryland that we're quite excited about.
		We are also integrating our major analytical instrumentation; our NMR group is already there, for example.  We will have an unveiling of a new electron microscopy suite which is at the University of Maryland which incorporates both FDA and University of Maryland staff actually working there at the university.  We're starting to design a mass spectrometry facility. 
		We're quite excited about the Center for Drug Evaluation move, a new lab that will be under construction shortly at White Oak, which is the other side of the campus from the Center for Food Safety.  So we're starting to explore options there with the joint utilization of equipment.
		But what we're looking for in the long term is a substantial integration with the university system in both training, training programs, continuing education program as well as in the research efforts.  But certainly there will be much more integration with the regulatory and research programs through the Joint Institute at Maryland because of the close proximity with the centers.
		DR. SCHWETZ:  Sam, the clearinghouse is also a big difference between JIFSAN and the Moffett Center.
		DR. PAGE:  Yes.  As brought up by Bern and Joe, one of the major points of emphasis here is risk analysis, including risk communication and part of the president's Food Safety Initiative, put the Risk Analysis Clearinghouse in JIFSAN at the university; and this is a consortium among all of the federal agencies involved in risk assessment.  This database will be available for people doing risk assessments, both in the public and private sector.
		DR. DOYLE:  Linda, one of the examples you use is a public education campaign using, addressing safe drug use. 
		DR. SUYDAM:  Yes.
		DR. DOYLE:  And I know FDA and U.S.D.A. and the industry has also been involved in a similar campaign with Fight Back and food safety.  GMOs is a major issue right now where we need a public education campaign.
		Has the FDA thought about some sort of a collaboration with industry, U.S.D.A., others, to do a similar thing?
		DR. SUYDAM:  We have thought about it, and in fact we do believe that there is a major public education component to the issue of GMOs, but we have to build that into our overall strategy and how we're going to deal with genetically modified organisms in food.  And I think it's just not right here at this moment that we're ready to do it.  
		VOICE:  The L word.
		DR. DAVIS:  The L word? 
		VOICE:  Labeling.
		DR. SUYDAM:  We thought the L word was leverage.
		DR. DOYLE:  I'm talking about just a general education of the public so they know what GMOs are and basic principles.  Not getting into those types of issues.
		DR. SUYDAM:  Good suggestion.
		DR. LANGER:  Yes, that's good.
		Other comments?
		DR. DOYLE:  What's happened to Fight Back?  You don't see much about it or hear much about it.
		DR. SUYDAM:  It's still being used extensively in public schools, and has received excellent evaluations.
		DR. DOYLE:  Great concept.  Novel.
		DR. SCHWETZ:  What we would like to do  from the standpoint of interaction with the Board is to continue to have dialogue with you on where we're going with leveraging, what the successes are, what problems we've encountered, and to get your reflections, your advice, your help, on how we can do this bigger and better and get more of an impact from it.
		So you will be hearing more about this as we go along.
		The next topic is one that I know is going to be brought back to you from time to time; because while the mission of the agency is, and we've talked about it in terms of safety and efficacy of products and protection of public health, the most important part of the agency in being able to do that is the people we have, obviously.  It isn't the laws, it isn't the other things, it isn't the brick and mortar; it's the people we have.
		One of the things we realize in the agency, and Mary may be talking about this some more, is that because of major hiring practices in the agency and earlier years, we have a bulge of people coming forward right now who are ready for retirement.  And on the one hand that represents a major concern of ours, because there's a huge amount of institutional memory in this bulge of people whom we will lose, but on the other hand it represents an opportunity for us to structure the agency of the future.
		I think a lot of hiring activities, especially in ‑‑ well, in good times, too; not just tight times ‑‑ we tend to think of replacing people one at a time.  And at least I guess I would admit that I haven't thought, in the past when I have had the opportunity to hire people, that I'm hiring the leadership of the agency in twenty years, or the leadership of NCTR or NIEHS or whatever it was I was involved in. 
		I think in reality we need to look at the hiring activities that are in front of us in the next few years as nothing short of the expectation that we need to hire these people so that they are in fact the best leaders that the agency could have in 20 years and not just that we're filling vacancies.
		And as a result, I wanted to have you get a feel for what is the profile of scientists in the agency today?  In a lot of different ways, not just expertise but other characteristics; and Mary Babcock is going to present some of that information.  She is the Director of our Office of Human Resources and Management Services.
		So you've got a lot of information in the packet that you received earlier and additional today, and it isn't our intent to have a one-time pass-through of all this detail and never come back to it.  What we hope is that we open the door for some questions today as opposed to put things to rest, because this is so important that we want to talk about recruitment and retention on an ongoing basis, and have you help us with those things that in effect will determine more what the agency is like in 20 years than guidances that we write today or products that we approve individually or whatever else.
		So this is something that we think is of major importance.  Mary, will you lead us through this? 
		MS. BABCOCK:  Yes.  Thank you very much.
	Retention and recruitment of scientists
	Flexibility of the profile of scientists
	Training, retraining of scientists
	Peer Review of Scientists
		[Slide]
		MS. BABCOCK:  I hope it's all right with you if I sit down; I have a lot of paper to shuffle, and I was afraid it would fall of the podium and embarrass me.
		Well, we're going to sort of shift gears from science to our scientists, and I have a lot of detailed information in your notebook that you might want to look at while I'm talking.  I've just put some highlights on the slides for the people in the audience.
		I also, in the blue packet I just handed out, I put an organizational chart of the Food and Drug Administration.  I'm not sure what kind of an orientation you had before you came here about what the organization looks like.
		And I know in FDA ‑‑ I'm sort of considered a newcomer ‑‑ that we throw a lot of acronyms around, and you might be sitting there saying, "Now what is CVM, or CFSAN?"  So hopefully with the organizational chart, it's going to be easier to follow along.
		One other thing I'd like to offer, if anyone's interested, and it might help in some of your quality reviews of our organizations is, we have further organizational charts that go down to every single organizational layer; it's a package that's about a half an inch thick.  But if anyone's interested, I certainly can provide that at some later date.
		The part of my organization that says management services is the organizational piece of FDA.
		[Slide] 
		The first handout in your package, and the next slide that I have is the overall onboard strength of FDA science.  And I've tried to highlight on the board here the major occupations that we work with in FDA.  In your first handout in your notebook you'll see down to the detail of every last individual scientific position we have.
		So this only highlights the major occupations.  I think you'll notice, the consumer safety officer is our biggest occupation; that's really the field investigators, for the most part.  We have consumer safety officers in every organization, but the bulk of those 1800 positions are the ones that are located in our field organizations.
		The require there, it's not necessarily a degree in science although we prefer a degree in science, they have to have at least 30 hours of science to qualify for that position.  All of our other scientific positions require a degree.  The majority of our scientists have a master's or Ph.D. degree.
		If you look in your notebook, you'll find any number of sorts of detail.  I wasn't going to bore you with all that, unless you have any questions on ‑‑ I've sorted it by center and by occupation.
		You'll notice, at the bottom of first chart there's a percentage for each one of our centers.  The total percent of FDA, 78 percent of our positions that we have are in fact scientific positions.  They're scientists or support positions for scientists, which only leaves 22 percent administrative staff.
		[Slide]
		The next major group of charts there is our attrition rates.  We have some issues with attrition.  We have high turnover in several of our scientific positions; one that's really critical to us is pharmacokinetist.  We basically can only keep a pharmacokinetist three years and they're out.  So we lose one third of that every year.  That's a problem in our recruitment and retention.
		For the most part, though, our attrition rate is fairly normal, typical government attrition rate.  Every year we recruit about 500 people to backfill the 500 people that we lose.  Unfortunately what we were future, as Bern just mentioned, at least one third of our senior staff, our higher graded people and our senior executives, are eligible to retire in the next two years.  Within the next five years, one third of our work force could walk out the door.  
		I think what you'll find in government service, if you're not familiar is, we have big bulges of hiring; we hired a lot of people during and after the Vietnam buildup and then these are the people who've had a 30 year career and they're ready to walk out the door.
		What we haven't had since then is any kind of big buildup in the federal government; there's been downsizing after downsizing depending on who the president is, starting I guess with Ronald Reagan, and it's sort of been down since then.
		So we've really kind of eliminated the big pipelines that we've had in the government to bring new people in.  So we're concerned about that.  We are involved in a work force planning process right now, but one thing we thought the board could help us with is identifying new and different places to recruit employees.
		Now, we've compared our attrition rate to the whole Department of Health and Human Services and also to NIH and CDC; and actually, FDA's attrition rate at least today is lower than the other organizations.  So we're doing as well as can be expected, I think in that area.
		One chart I did put together is the, kind of looking at the attrition within one of our centers.  The Center for Drug Evaluation and Research, this is 1999 they took a look at it, ‑‑ and those numbers might be hard to read I'm sorry, that was the best ‑‑.
		The majority of the people we lose in the Center for Drug Evaluation go to private sector.  What we're finding, they come into FDA, they learn our business, they learn how to do drug reviews, and then they become very valuable to industry, and they can command huge salaries.
		So we're sort of learning to live with that and just ‑‑ we're trying to change our culture a little to, instead of bringing people in and trying to keep them 30 years, we're trying to figure out how to take advantage of new, young people coming in with some technical knowledge, keeping them for five years, and then bringing a new group in behind them.  So it's sort of a change in the way we've been doing business.
		It kind of matches the way the younger generation is coming into the work force; they're not prepared to stay 30 years in a career any longer, they'll be moving around.
		[Slide] 
		As far as projected hiring, in addition to the 500 positions that we normally hire in a year, that's just our normal attrition.  We're doing some projection for the year 2001.  In the year 2001, we've put together some budget strategy that we're going forward to Congress with to hopefully get some new money in FDA, and right along with the budget strategy we've tried to identify what kind of people and how many we would be hiring if in fact we're successful with Congress.
		So this just gives you highlights of the new positions we would be hiring.  Altogether, we're projecting another 450 to 500 positions if we get the increases we're asking for.  So next year we might be looking at hiring 1,000 people.
		So just to pique your interest, if you know people who are going to be looking for jobs out of the universities.
		[Slide]
		I thought maybe I'd talk a little bit about our hiring authorities.  I don't want to bore you with the federal issues but FDA is lucky in a way, as a federal agency we have a lot of flexibility other government agencies don't have. 
		Normal federal government hiring is done under what we call Title 5, which is the laws, rules, regulations that govern hiring.  It's a very tedious process, it takes a long time.  If we started a vacancy announcement, it might be six months or more before somebody walks in the door using the normal federal hiring process.
		I know it's long, but it's just the way it goes; we also deal with veteran's preference laws and things like that.
		FDA has the advantage of having two other laws that govern hiring.  One is our Title 38, which is for medical doctors.  Title 38 is really for the Veterans Administration, for their hospitals hiring doctors, but they've expanded it to the Food and Drug Administration.
		So we're able to hire medical doctors without going through a whole lot of competition and paperwork, and we also are able to pay them much higher salaries than the normal government employee would be hired.
		So our retention with medical doctors under this new Title 38 authority has been much better.  In the past we were losing one doctor for every one we hired, so we never got ahead with the number of doctors we had on board.  We'd hire one and one would leave, so we were always like a hundred underneath.
		With this new pay and hiring authority, with Title 38, we've been able to add 100 doctors just this year.  So the medical doctor is really key to our drug reviews, in particular; they're kind of the final reviewer, so it's important for us to have them on board and have them trained in the drug review process.
		The Center for Drug Evaluation is really where most of our medical doctors are located.
		We also have the advantage of the Public Health Service Act, the Title 42, we're calling it, where we can really go out, identify good people, and bring them on board immediately.  We don't have to go through much of any process.
		Title 42 gives us authority to pay up to $2 00,000, which is the current cap on the federal government.  That's what the president's salary is, so we can't go beyond $200,000 at this point.  We are not authorized to pay that much, but at least we have this authority to expand some of our current salaries.
		So that's pretty exciting that we have this kind of flexibility; so that if we can target our recruitment, if we can find the right schools or the right places to go, we can in fact offer jobs a lot faster than the normal federal process.
		We also have several what I call contract authorities.  This is where we can pay stipends to bring students on board, or faculty from academia or other places where we can train them, we can bring them on board to work in our lab; we have over 50 labs across the country where there's a lot of education and sharing we can do, bringing postdocs or just professional documents on board to work in our labs and work with our employees, and learn our business, and we can learn from them in the state of the art.
		We used that, particularly in the NCTR, we use the ORISE program, where it's the Oak Ridge Institute for Science and Education, where we partner with the University of Arkansas.
		One thing we've put together for you, and I hope at some point between the next meeting you'll have a chance to look at, we actually went through every single person we hired, every scientist we hired last year in FDA ‑‑ and I believe it's the last handout in your notebook.  And we did a profile that includes the grade level, and I'll give you a chart with the grade levels.  The degree, the school they came from, prior experience and any honors and associations that the person had.
		What I think we'd like to ask the Science Board, and I think this is what Bern had in mind is, to just quickly look through it and see, are we targeting the right schools?  Are we getting the right quality of science in the organization?  Should we be doing something different.  To me it looks pretty impressive that the level of people we get, the quality of the person we attract into FDA; but I don't know all the scientific ‑‑ I don't know if hiring a medical officer from certain schools is a good thing, or may be a mediocre thing.
		So I think what we'd like to do is have some kind of a response back from the Science Board saying, "You're really hiring A quality students or B quality students" type feedback.
		Do you all see that in the back of your notebook?  Okay. 
		The other couple things I've done, as far as recruitment of scientists; this is our brochure that we use when we go to college campuses or job fairs or other kinds of recruitment at the entry level.  It's just information about FDA; it's got our web site, it's got our offices listed, tells a little bit about the organization, and we have inserts about individual occupations that we have.
		So you can take that or leave it, whatever.  One of the things we have found is, with the jobs that we've advertised over the last year, we now put them up on the Internet through the Office of Personnel Management, which covers the whole federal government.
		And the response to our announcements has been maybe triple-fold over what we used to get, as far as people we see.  Unfortunately, even though last year we looked at 12,000 applications, we only selected 250 people.  So we're doing a lot of work; we're reviewing a lot of applications but we're not necessarily reaching the people that perhaps we need to reach.
		So that's just the recruitment material we use.  The other thing I put in the blue folder, and I apologize, I didn't get this into the book before it was time.  Just some examples of the kind of vacancy announcements we use.  There's one for a medical officer, and it talks about all the medical specialties and how people apply for a position, if you're interested in looking at something like that.
		One of the things we've talked about for a long time is how to simplify the process to get into the federal system.  So any suggestions you might have on that would be appreciated.
		Are there any questions about recruitment before I go ‑‑ I thought I'd talk a little bit about our peer review process.
		DR. NEREM:  Just a couple comments.  As far as whether you're hiring from the right schools, one of the things you might do is talk to some of the bigger companies that bring products before you, and find out where they're recruiting from.  Because in some sense, you ought to be recruiting from the same places.
		The other thing I was going to comment on, if you add up all the engineers you have, I think it's 179.  I'm actually surprised you might not have more.  But one of the emerging things in education is the obvious attractiveness of young people to the bio-world.  A lot of those people are going into either biomedical engineering or bioengineering, and it's not clear to me that there's in fact enough jobs in industry to take care of them, all these bright young people, and that might be a good area to recruit in because these people are coming with a combination of biological background and a more engineering product-oriented background, and that might be a good match for FDA.
		DR. LANGER:  Go ahead.
		DR. DAVIS:  As I thumb through the sheet here looking at the schools, what's strikingly obvious to me is that you're not doing a great job of recruiting from historical black colleges.  Now whether it's that you aren't giving them or they aren't showing up ‑‑ but as I just look through here, the only school I see you consistently getting people is Howard, which is located right here in the area, and that sort of makes sense.
		I know when Dr. Sullivan, past head of HHS was here, that was a program he started down at Moorehouse Med School, I think it was called EMS, that he was involved in.  There's a consortium of historical black colleges who have medical programs of some persuasion; med schools, dental schools, veterinary schools, pharmacy schools, et cetera.  And I know he has gone back to Moorehouse, and his brother's there, and they're still very active in that, and I've been involved.  I would say if you're going to find people from sources you don't routinely recruit from, you're going to have to go get them, and that would be a good place to look.
		MS. BABCOCK:  Actually, we have quite an active program for reaching out, for diversity.  Right now we have a major effort going on in the Hispanic area.  We are seriously underrepresented in the Hispanic community, so we've been working with partnering with the universities, University of Puerto Rico, University of New Mexico, and a university in Texas that has a high Hispanic population.
		We do routinely go to the historically black colleges and universities to do recruitment.
		DR. DAVIS:  Well, that's actually an organization, so even just a one-off --
		MS. BABCOCK:  Right.  We have a list of them; I think there are 150.
		DR. DAVIS:  ‑‑ that's a great way ‑‑ they normally bring about 8,000 college students together for a medical forum every year, so it's sort of a one-time sort of everybody's there.
		The other point I'd make is you made the comment that you're going to lose one-third of your force due to just people going out because of age.  And that it sounded like you were saying that you were sort of acquiescing that that was just going to happen, but you were going to try to ‑‑ you're changing the mode of operation that, we're going to try to get people in and keep them for a few years, knowing they're going to go away.  We're just going to lose a lot of these young people.
		That scares me as a person who brings an application for it, because it sounds like there's always going to be people sitting there fairly new.  You know, that these reviewers, at least that I see, are going to be people with two years, three years' experience.  Just keep turning over all the time.  And that's sort of frightening.
		MS. BABCOCK:  One of the things we've talked about is, if we identify somebody who's really on a fast track, who is really an excellent reviewer, figuring out ways to pay them more money to keep them in FDA longer.
		We figure it takes two to three years to train somebody to be a really good reviewer, to follow drug from the beginning to the end.  So it hurts us when we lose people that quickly.  So we're trying to come up with incentive programs where we can keep people longer.
		Unfortunately I think part of our problem is that industry is able to pay so well for some of these people that we can't compete within this federal system.
		Now my comment was more that 30 years ago people started a career and expected to stay when placed for 30 years.  It was kind of a lifelong career and we've had a lot people in FDA who have been here 30-35 years.  And now that's not the model anymore; at least all the data shows that people are more inclined to have seven or eight or nine careers throughout their 30 years.
		So I think it's just a matter that we have to kind of rethink how we treat our people, and try and keep the best ones as long as we can, but just face the fact that that's going to happen.
		DR. DAVIS:  We have the same problem in industry, and when I first came in there were a glut of people who were on that site who might have been there 30 years.  But now people move from company to company to company, so industry fights the same battle, "How do we keep our good people without throwing up our hands?"
		MS. BABCOCK:  We've also talked about, how can we attract people who have had their career in industry, at the end of, when they retire bring them back into FDA?  One of our issues is, the ethics issue of a lot of private sector people's retirement is in stock holdings that they have, and of course we have very significant rules that govern how much ‑‑ you really can't hold any stock in regulated industry.
		So we have a couple issues there that we've been talking about.  You know, is there anything we could do if we wanted to attract somebody who retires from an industry after 30 years and bring them onto FDA?  So we're trying to be creative as we can with some of these issues.
		DR. LANGER:  Ed?
		DR. SCOLNICK:  It looks like you're getting Ph.D.s from local schools.  And you're not getting a wide variety of schools represented.  So the question is, you know I've found over the years in recruiting that the best recruiters are not ‑‑ don't take this wrong ‑‑ they're not the HR people, they're the scientists.  
		So what is your program where people who run your divisions and run your centers, the scientists that lead your organization, in an organization you want to be more science-based, what are they doing to help bring in talent, given your restraints, and your pay scale, which is difficult?
		MS. BABCOCK:  Actually, when we have big recruitment programs, and I think Alan Rulis will be talking about this a little bit this afternoon, but when we have big numbers of people that we're going to try and recruit for one center or something, they actually are the ones who go out and do either college recruitment or ‑‑ 
		DR. SCOLNICK:  No, but you have a constant need for people.  Recruiting is not filling a job, recruiting is a lifelong process of establishing relationships with science departments, constantly making your presence known, getting your people known, getting the young people to know you exist, comfortable with you and constantly applying to fill your turnover as well as your big boluses.
		And if you're really serious about upgrading the scientific staff of FDA, I think you really need to look at how you recruit.  Because if I take you at face value about the losses that Harold talked about and look at where you're getting your scientists, I think you have a major problem, and you really want to upgrade the science in the FDA with what you're doing, you have a big problem.  You have an enormous problem.  
		You'll never fill the jobs that you need with the quality of people you need, and if this is the best that can be done, you need to rethink the whole structure of how regulatory reviews are done for products that affect the health of people.  You'll never improve.
		DR. NEREM:  I don't know how Merck and Amgen and SmithKline do it, but I know some of the major medical device companies that basically target seven, eight universities.  And those are the ones that they're establishing specific relationships with.
		DR. DAVIS:  That's what everybody does. 
		DR. SCOLNICK:  That's what everybody does.  That is the mode for all the industry recruiting, whether it's law firms or pharmaceutical firms or whatever.
		DR. DAVIS:  That's sort of what I meant by historical black colleges.  Just as an example, you can't show up once and try to recruit.  People look for relationships.
		In our company, we actually ‑‑ this is public knowledge ‑‑ we actually pay members of our scientific staff for recruiting people.  Because we recognize that we're in competition with other people.  Now, I'm not sure that the government can do that, but we have an ongoing ‑‑ it's been going the last five years, an internal thing where if you recruit a scientist and the more top-notch that scientist is, the higher level, the more you get paid.
		Now directors and above don't get to participate in that so it doesn't count for me, but for more junior faculty, it's a way of getting the scientists themselves involved in their alma maters or in their trade associations or whatever, to help find these people.
		DR. SUNDLOF:  Well, the way the NCTR does it ‑‑ 
		[Simultaneous discussion]
		DR. LANGER:  Is there any type of ‑‑ it's really a good point because I just think about my students, my graduate students and undergraduates.  If they have a relationship by knowing people at the company, the chances of them going there just go up tremendously.
		So the question that people are raising is, are there any ‑‑ and it's actually very consistent; the schools that are closest to here are the ones that you're getting.  So if there are ways to try to have people speak or join research programs or something like that at universities, in other words as an investment for your future, I think it's ‑‑ trying to come up with a creative strategy ‑‑ I mean, Ed is absolutely right.  
		DR. SUYDAM:  I think that's actually one of outcomes that we pulled from the leveraging initiative as well.  Because if you start building partnerships with institutions across the country, then hopefully those partnerships will yield you people that will want to come to work at the FDA.
		DR. SCOLNICK:  If you reach out for your review process and your information process more widely, you'll build the kind of research partnerships ‑‑ I mean, I agree with you.  I'm actually quite worried, looking at this background information.
		DR. LANGER:  And I think what you're saying is good, but I don't know if it goes far enough.  In other words, the question is, how do you get really the students exposed?  Like if you want to get good young people, how do they get exposed to what you're doing?
		DR. SUYDAM:  Yes.  I understand what you're saying, but it could also be that FDA scientists would be out working within the university.
		DR. LANGER:  Right.
		DR. SUYDAM:  Hoping to give lectures and --
		DR. LANGER:  Exactly
		DR. SUYDAM:  ‑‑ being part of an ongoing curriculum.  And in fact I know we do have some Center for Drug employees who are actually in a curriculum program at Duke, in the Duke clinical research system, which gives them exposure to the medical students at Duke.
		So those are the kinds of programs we have to build on.
		DR. LANGER:  I'm also ‑‑ go ahead.
		DR. NESTLE:  I just want to point out that the CFSAN report had a number of suggestions along those lines about postdocs and internships and people taking positions at universities and adjuncting and all of those were in there, for just exactly this purpose.
		DR. FENNEMA:  Another approach, particularly at the master of science level, which is incredibly effective, is a program of internships, summer internships for undergraduate students to come into your laboratories.
		I know from our experiences in Wisconsin that that is a very, very effective employment tool, and is one you might think about.
		MS. BABCOCK:  We have those mechanisms; it's just that we haven't been using them as much as we probably should.
		DR. NESTLE:  Every student in our department at every level does an internship, and they, I would say 60 percent get jobs in the places where they do their internship.  I mean some astonishing percentage.  It may even be higher.
		DR. SCOLNICK:  I think you have a crisis, and I don't want to overstate it, but I really believe it, and Harold and I share the same view.
		DR. DAVIS:  It's just if you look at regrettably the salary structure, you know, which is not your doing, it's the government's doing, what industry is paying them, if you look at - you see 30 percent of your people, senior people could walk at any time, and if you look at where you're getting people from, primarily just the local schools, there's no way the local schools can make up the differences for all the head count that you have, and then you factor on top of that the inequality of salary that can be offered. It just seems frightening.
		DR. NESTLE:  And the ten days vacation.  That was one that made my heart sink.  
		DR. DAVIS:  We don't take a vacation anyway --
		DR. NESTLE:  It doesn't matter; it's the principle of the thing. 
		MS. BABCOCK:  Some of these new hiring authorities do give it some flexibility in the salary schedule.  So that's going to help, I think somewhat.  We've hired a consultant firm, Toffler & Martin, to help us put together kind of a future vision of where we want to go in the organization, how to get there?  It's really aimed at work force planning and a lot of the ideas we're talking about that you're suggesting in fact are in there.
		The senior staff of FDA has really bought in to trying to do something a different way.  So I think we're going in the right direction.
		DR. ROSENBERG:  Given how serious the problem is, and I agree with you on the seriousness, the point you made earlier about trying to at least in a temporary mode use industry retirees I think is an excellent idea.  It will help supplement that.
		But you've got to find a way to allow those people to participate; just because they have stock in the company they worked for all their lives ‑‑.
		DR. SCOLNICK:  Or more university reviewers, or really enlist, or really go to the universities and ‑‑ it's a contentious issue that I know has been around for a long time, that is, the use of people in universities to supplement your reviewers in a really much more significant way.
		I really think we cannot understate the level of seriousness of this problem.  It's the single biggest problem I've heard today.
		DR. DAVIS:  Have you looked at the former pay scales in terms of what they guesstimate people in industry make?  Because the question I have is, are you holding your own or losing ground over time?  If you looked at it over the last five years, in terms of trying to look at a GS-somebody versus an RS-somebody in industry, comparable positions, would you say you're losing ground or ‑‑?
		MS. BABCOCK:  I would say, until we were able to have this new flexibility, we were losing ground.
		Now one of the things we've tried to do in the past, we have what we call recruitment and retention bonuses where we can pay up to 25 percent additional salary.  One of the requirements that the government put on us is that the employee wanted to give a retention bonus had to have a legitimate job offer in their hand, or at least a potential job offer in their hand.
		Every time we'd send somebody off to get a job offer, they took the job.
		(Laughter) 
		So it was kind of a Catch-22.
		DR. DAVIS:  That's a program that worked.  
		And again, SGE programs, or how do politicians who get elected, who hold stock?  Again there are perhaps not nearly as many of them; but they don't sell their stock, they ‑‑ don't they put it in trust or something?
		DR. LANGER:  Varmus had a blind trust or something like that.
		MS. BABCOCK:  There is such a thing as a blind trust.  The problem with FDA is, we have a published list of stocks you cannot hold.  And so anybody who is being considered for the job would know up front what stocks.  So it's hard to have a blind trust when you already know you can't hold that stock.  It's been a little Catch-22 we've been dealing with, but ‑‑.
		I think every commissioner that's come in to FDA has in fact had to sell.
		DR. NESTLE:  Exactly.
		MS. BABCOCK:  Yes, even the political.
		DR. SCOLNICK:  I don't want to give you a specific solution to that, but the kind of thing ‑‑ and it really depends on cooperation.  In theory the government could contract with a big company that runs mutual funds and work out transition position for people where for the time they were there, their stocks were managed in a different way by an outside company where they would give up what is called beneficial control for the time they were in the agency, for the time they were in the government.  And they would have to do that.  Yet they wouldn't lose financially, because it would be being managed presumably in some kind of significant professional way. 
		DR. LANGER:  Maybe even better.
		DR. SCOLNICK:  Maybe better. Probably better. 
		(Laughter) 
		DR. SCOLNICK:  But I mean you could just think out of the box about to do that in order to enhance your ability to attract talent.
		DR. FENNEMA:  Well, there's another aspect to this.  This isn't always a matter of salary alone.  If it were, you wouldn't have anybody left in the universities.
		So the other major aspect of this is job contentment, and there's a lot of facets to this particular problem and many of them which I think you can work on, and should work on.  Professional development is one of those.  You know, the pleasantness of their environment is another one.  And you can go on and on with all these kinds of things.
		But that is incredibly important; somebody who really likes their job, they're not going to be tempted away by another $10,000 a year.
		DR. NEREM:  Bern said it earlier; the people you recruit in the next few years is going to be the leadership 20 years from now, and you've got to have a strategy for recruiting and for professional growth that's going to produce those leaders 20 years from now.
		DR. DAVIS:  And assuming 50 percent of those people are going to be gone in ten years, sort of in my opinion, it's not a good strategy for looking at who potential leaders are.  Because you're saying half the people we bring in, or something, are going to be gone in ten years.
		DR. SCHWETZ:  Harold, I would pose an alternate way of looking at that, changing it from a problem maybe to an opportunity.  When you have a high turnover in some categories like certain of the reviewers, we have a training program going on, but we're not calling it that.  And we're always hired under the level it takes to get that job done.  It would seem as though it would make more sense, but it may not to you, as a company submitting work, that we actually call this a training program.
		And what we want to do is, eventually after three years, be able to hire the best and the brightest of the people who are in the training program; then you do like you do with postdocs: you bring a bunch of them in and you say "There's no promise of long-term employment, but this is a wonderful training opportunity for you wherever you go.  And we're going to take on twice as many or three times as many as we would ever want knowing that we're going to very selectively just pick out a few that become who we want around 20 years from now."
		We have a training program, we just don't call it that.  They just keep disappearing.  Call it a training program and overhire, and pick the best out of it.
		DR. DAVIS:  Well, if you can afford to hire twice as many as you're going to need three-four years from now, that's a different story.  I guess I'm under the impression that the hiring quotas are so tight that the FTEs you've got are basically what you need, and so you're always playing catch-up.
		And oftentimes the people who are leaving, other people who are frustrated by whatever they're frustrated by, low salaries, poor working conditions, don't get to go to enough meetings ‑‑ whatever the reason that oftentimes we find it's the best and brightest who are going other places because they have the opportunity to go other places.
		If you're losing bad people, you don't really care, but it's the good people that you really worry about, and the good people always have an opportunity to go somewhere else.
		DR. SCHWETZ:  But there are training programs for epidemiologists and other groups that are run that way.
		DR. LANGER:  This really seems like there are two issues ‑‑ I mean it's more than two issues, but two ways of looking at it are first there's the recruitment of young people -- and I think some of the points that are being made about trying to get it to the universities are very important ‑‑ then the other thing is, that concerned me when I listened to this is the large percentage of people ‑‑ maybe it happens other places, too ‑‑ but the large percentage of people that leave so quickly.  And how do you incent them to stay?
		One question I had is, I don't have enough of a sense of, like if somebody does a great job do they get some great title or some great honor?  Or what happens?  Do they just get like a promotion of like $10,000?
		DR. SCHWETZ:  We give them more work.
		MS. BABCOCK:  Yes, we give them more work.
		(Laughter) 
		DR. LANGER:  That's the reward, basically.
		MS. BABCOCK:  We do have a reward and recognition program, but not the kind of money you're talking about.
		DR. LANGER:  No, I'm not even necessarily talking about money.  Like what universities do, say take Bob, he's a professor at Georgia Tech, stuff like that.  Do you do things like ‑‑ a lot of people have chairs.  In other words, there's ways of giving people some kind of recognizes that I think enhance ‑‑ that make them feel better.
		MS. BABCOCK:  One thing we're talking about now, and I think we're starting to do it in Center for Veterinary Medicine, is reward people who have done an extraordinary job with sabbaticals.  We have not used the sabbatical concept too much in FDA, but whether it be a mini-sabbatical or a yearlong --
		DR. LANGER:  Well, I think that's a good thing anyhow, for other reasons we talked about.
		MS. BABCOCK:  Well, yes, but with the resource issues we have, we haven't done that a lot.  Dr. Henney is very interested, though, in starting to roll that kind of a program out.
		DR. NESTLE:  I hate to get down and dirty, but it's late in the afternoon --
		DR. LANGER:  That's okay, you go ahead.
		DR. NESTLE:  One of the things that was just very, very evident in the CFSAN review, was how demoralized the staff was.  And the issues were very apparent, they just didn't feel like they had any control over their work.
		Every study that I've ever seen on job satisfaction lists control right at the top.  You know, controlling your time, controlling what you're working on, controlling when you come and go, what other activities you're involved in.
		Having been a federal employee myself, I fled back to the university.  I couldn't stand it.  It was just awful.  And some of that has to be beyond what the federal rules are.
		MS. BABCOCK:  Well, actually, I think we have created and rolled out some of the most flexible and creative programs to address those under our quality of work life issue.  One of the problems my staff and I have been having is to get our supervisors to accept it.
		For instance, we created a program that we call Any 80. The normal two week work period is 80 hours.  And the government requirement is that you have core hours that every individual has to be there during core hours.  In this program we said your core hours are Wednesday from 11 to 12.  So it's the program where you have to come to lunch on Wednesday.
		And other than that, you can flex from midnight on Sunday night to midnight Saturday, within a two week period, as long as you put 80 hours in.  So the vision was, you know, you could work 12 hours one day, 3 hours the next, don't come to work the next, and fit your family around the work schedule.
		And believe me, this is the first in the federal government; no other agency has this Any 80 policy.  Right now I would guess that maybe 10 percent of our employees can take advantage of it, because our supervisors haven't been able to let go of the control, and they're afraid that they won't be there for industry, so the core hours now ‑‑ I mean, managers still set core hours, so they've set core hours Monday through Friday from 9 to 3, so you can flex a little bit around that, but it hasn't really worked as well as I would have liked to have seen it.
	But we're trying to come up with some new creative ideas for our employees, and I'm sure the staff will say that ‑‑ we've been pretty out there with some, the quality of work life initiatives, we just ‑‑ 
		DR. NESTLE:  The things that drove me ‑‑ he wants to know what my ‑‑ 
		DR. DAVIS:  No; I'm just being facetious.
		DR. NESTLE:  You're being facetious.  You want to know what it was like?
		MS. BABCOCK:  We also have telecommuting, working at home.  We're trying to push that program right now.  About 4 percent of our employees are able to work at home at least one day a pay period.  We'd like to see that.
		One of the proposals that I have in my workforce plan is to make it mandatory for supervisors to work at home at least one day a month so that they get an idea that you're not just there goofing off, that you're actually doing something productive at home.
		But we have issues with security and computers and things like that.
		DR. NEREM:  I thought maybe you wanted the supervisors to stay home to minimize their damage to FDA --
		(Laughter) 
		MS. BABCOCK:  But we are trying to work with some of those family-friendly programs.
		DR. SUYDAM:  I think Mary and her staff have worked very hard to try to and improve the quality of work life within FDA.  I think that there are other things that have worked in just the opposite direction.  And some of those other things are clearly the limitations of our budget, in that we can't afford to send people to professional meetings as much as they should be going to professional meetings.
		We can't afford to do very many sabbaticals.  I mean, there's just a very limited number of those, because we don't have the staff to fill behind them.  And then when you're operating under the deadlines that we have in a lot of our programs, where you have statutory obligations to review products.  In the prescription drug user fee area where we have performance goals and performance measures, if you don't have staff on board and if they're not there, you can't meet those performance goals.
		So those are all the forces that are forcing in this direction while we are trying to improve the quality of life in the other direction as well.
		DR. NEREM:  On a per capita basis, what is the travel budget for a professional at FDA annually to go to professional meetings?
		MS. BABCOCK:  I can tell you what we spend on training and development is 1.3 percent of our total budget.  Now I understand in industry, in the pharmaceutical companies, it's about 2.5 percent.  
		DR. NEREM:  If I was an employee --
		MS. BABCOCK:  It's about $1400 per employee.
		DR. SUYDAM:  In terms of travel, I think it's even less.
		MS. BABCOCK:  I'm talking training and development.  So the cost of attending a conference plus the travel to get there and whatever else.  The average employee gets 4.4 days of training a year.  That's rolled up in an average.
		DR. SCOLNICK:  So here you're looking at probably one meeting.
		DR. SUYDAM:  One meeting.  And that's unusual.  That's not 100 percent.
		DR. NESTLE:  I don't understand.  The very wealthy university that I work for has a salary scale that's just like FDA's, it has a budget for meetings that's just like FDA's, and it has happy campers who work 80 and 100 hours a week and are there all day, all night, doing the work because they choose, they control their own work flow.
		DR. SUYDAM:  Well, and I think that perhaps you're getting the wrong impression if you think that most FDA employees are not happy campers.  I think we've done the quality of work life survey, and the morale survey shows that FDA's morale is among the highest in federal agencies.
		DR. NESTLE:  Then why are they leaving?
		DR. SUYDAM:  Our attrition rate is only 5.8 percent That is not a high attrition rate.  That's much lower than the average government-wide.
		DR. NESTLE:  Then why are you worried about it?
		MS. BABCOCK:  I'm just projecting --
		DR. SUYDAM:  She's talking about retirements.
		DR. SCOLNICK:  No, but I don't think that's the only problem.  The problem is in who you can attract.
		DR. LANGER:  Right.  That is the problem.  I think that, as I look at it, is the key problem.  The problem is the recruiting at the early stage, the young people.
		DR. DAVIS:  They don't have the luxury of working on whether they want to work on it.  They're not writing specific grants to pick their areas, et cetera.  They're spending taxpayer dollars on things that someone else has decided is important.
		I can understand that; I don't think you have the luxury, necessarily in a government lab to say "I will do whatever I want to do" as a major part of what you do.  So that's not going to be where you're going to be able to make people happy.  That's the real world.
		But it's those other things, I think, in terms of who you get to attract.  People feel good about coming to work because the relationship with their colleagues, supervisors, the kind of place they work --
		DR. SCOLNICK:  Intellectual atmosphere.
		DR. DAVIS:  ‑‑ intellectual atmosphere, challenging, that kind ‑‑.  I think you do have a problem when people can't go to meetings.  I think it's excellent, the kind of thing that Susan was talking about training, hooking up with industry, et cetera.  Because if you can only send scientists to one meeting a year, and technology is just booming, it's very hard to think that these people can keep up.
		DR. SCOLNICK:  I would be very complimentary about that program.  I think it's one of the most forward going and exciting things I heard.  And I don't know the agency well enough, but I think more of those and then making sure that the place that you're recruiting know about those programs will help you recruit better, more better.
		DR. LANGER:  I think so, too.  I think all these kinds of things where you're getting interaction with new types of people, industry, universities I think are very positive in many ways.
		DR. SCHWETZ:  You've made some good suggestions on this as well as other things earlier in the day.  But I would come back to my statement earlier and ask you to think more about this, and I'd like to come back to it again in another meeting, and that is, if you were charged with hiring the leadership of the FDA 20 years from now, how would you do it?
		This information gives you an idea of the recent past practice and where we got people from and what level they were, what kind of people they were.  
		What Alan is going to talk about later this afternoon is another current practice that's going to put 50 people into the FDA.  What I would like to know from you is whether or not you have ideas that are more out of the box and how we can do that to solve some of the problems that we're all concerned about; and things that ‑‑ I mean, after you work in the federal government so long you tend to be confined by the thinking of the federal government.  And it sure would be nice to have innovative linking.
		DR. LANGER:  Well, maybe we should go on.
		DR. SCHWETZ:  Mary's going to talk about peer review 
		DR. LANGER:  Okay.
		[Slide]
		MS. BABCOCK:  I should have started with our quality of work life effort, because I think I'm leaving you with the wrong impression, that we're not trying to improve ‑‑ and I don't know how long ago the CFSAN ‑‑ 
		VOICES:  No, no, no.  We don't believe that.  [Simultaneous discussion.]
		MS. BABCOCK:  Okay.  I'm going to talk a little bit about our peer review of our scientists in the agency, and this is really a promotion, how we set pay, and it's really aimed at our higher level employees.  People ‑‑ I don't know if you're familiar with the government pay system.  I did put a pay schedule in your handout so you'll have an idea.
		There are basically 15 levels.  The 13 level is what we call our journeyman level.  So anyone who goes above the 13 level for the majority positions -- for people in the audience who are in at the 13, I don't want to ‑‑.  To get above that we have what we call our peer review.  Essentially what it is is the people in Human Resources don't have the scientific knowledge or skills to really assess the level of science that's going on in an individual's work, what their publications mean, what kind of science they're doing, what kind of skill levels they have.
		So we put together peer review committees for the various occupations.  A peer review normally, a supervisor nominates an employee for a promotion.  It can be after one year; generally it's between three and five years, and the promotion is a fairly significant bump up; it's at about a six percent increase.
		We then have a chief reviewer who does a lot of work interviewing peers, interviewing the employee themselves, interviewing the supervisors, interviewing experts outside the federal agencies, whatever it takes.  And then they present it to a peer review committee which is usually seven to eight scientists who understand the occupation.
		The majority of our peer review committees are made up of scientists from all the centers or at least representative of all the centers.  We have about 50 or 60 people in FDA who participate in our peer review processes.
		I have a list of the various committees here; we have one obviously for reviewers, both premarket and postmarket surveillance scientists; those are the reviewers that are in Center for Biologics and Center for Drugs.
		We have one for medical officers, we have one for the consumer safety officers; those really are compliance people in the field.  We have one for research scientists.  And all these peer review panels are done a little differently; in the research one for instance, we bring scientists from outside of FDA.  We often use people from NIH or the Research Triangle in North Carolina, places like that.  And then we have one for our support services, in our field labs.
		Essentially the employee goes through the peer review, it's a very exciting, robust process.  There often the chief investigator will give a presentation at the peer review, and then it's determined whether the person in fact deserves a promotion or doesn't deserve a promotion.  
		One of the things I included in the blue folder that I handed out is an actual submission of a peer review.   I do have the permission of the employee to share it with you; but it gives you an example, I think it's the last thing in that blue folder, an example of the kind of information we're looking for, the level of publications the person had.  It's the one that starts with Roger Williams.
		Just to give you an idea of the level of research and responsibility that we look for when we're ready to promote somebody to the next level.  We do that for all of our scientific positions.  It's generally been working as a good process.  If somebody does not get accepted for promotion, the peer review panel gives feedback on where the employee needs to move, what they need to do to reach the level for the next promotion.  It's good feedback for the supervisor who put the employee in as to what they are not accomplishing, if in fact they don't achieve the promotion.
		So we think it's a process that's working very well in FDA.  Something new we've started in a couple of our centers is what we're calling our master reviewer program, where we're bumping them up even one further level:  When somebody really understands a review from beginning to end, they understand technology, they can communicate with other people, they have a broader knowledge than just the narrow scientific field that they're working on.  
		So our master reviewer program I think will also be good to keep the quality of science at the higher levels, to keep it in check.
		That's kind of a quick review.  There is more detailed information; we have the peer review that's on our home page that employees have access to.
		Just recently we have a new union in FDA ‑‑ I don't know if you're aware of that.  We have the National Treasury Employee Union, NTEU, a very active federal union.  We just negotiated the contract with them, and one of the things that they were very set on is having self-nomination for peer review.  In the past only a supervisor could nominate somebody for promotion.
		We agreed that employees could self-nominate if they felt, for whatever reason, their supervisor didn't like them, didn't care, didn't appreciate what they were doing.  We  now have a process where they can put themselves in for peer review.
		We haven't tested that yet, but we're looking forward to our first case of self-nomination.
		DR. DAVIS:  But you get to pick ‑‑ who picks the committee, though, of the reviewer?
		MS. BABCOCK:  In the self-nomination, they can nominate 3 people, but management has the final say on who is on the peer review committee.  Ordinarily, for our other peer review committees, we have a chairperson and members that we can call upon to, when we have cases to present.
		Over the last year we did approximately a hundred of these peer reviews, a hundred cases were processed.  And I think I have some numbers in there if you're interested, of the number of scientific positions covered by peer review and the number that we processed in the last year.
		DR. DAVIS:  Of the 100, how many successfully were promoted?
		AUDIENCE:  112.
		MS. BABCOCK:  Oh, those were the ones promoted?  Do you have any idea how many cases you did not?
		AUDIENCE:  Probably about, I remember 10 to 15.
		MS. BABCOCK:  So 10 percent maybe don't make it through the process?
		AUDIENCE:  You have cyclical reviews for some of those.
		MS. BABCOCK:  Yes in some cases, particularly in our research areas, we have a cyclical review, either a three year or five year review, just to make sure scientists are keeping up with what they're supposed to be keeping up with.
		DR. SCHWETZ:  Well, the real word there is "mandatory."
		MS. BABCOCK:  Ah, the cyclical ‑‑. 
		DR. SCHWETZ:  Cyclical; just be clear, it's mandatory.
		DR. SUNDLOF:  And in some instances individuals have been demoted, as well, through that process.
		DR. SCHWETZ:  So when you have mandatory reviews and a promotion process, you don't get very many promotions in your career, you're going to have a lot of people not being promoted who are undergoing review.  Just to be sure that they're keeping up to where they need to be.
		DR. DAVIS:  But you've had GS-13s, for instance, demoted to a 12?  Is that what you mean?
		DR. SUNDLOF:  We've had GS-15s demoted to 14s.
		MS. BABCOCK:  That really doesn't happen that often.
		DR. SUNDLOF:  Not often, but --
		MS. BABCOCK:  But it's out there, our employees know it's possible, so they try and keep up with where they are.
		DR. ANDERS:  Do these cyclical reviews mean that a person can go three years without any review?  Or is there an annual review.
		MS. BABCOCK:  No, there is an annual performance review.  This is sort of a separate system from the day-to-day performance issues.
		Okay, as far as professional development, we talked a little bit about our training expense and how much time and effort we put into training.  Some of the things we're working on, I mentioned the sabbatical program, and that's something that Dr. Henney is very interested in.  Whether it's for reward or just for development, I think we'll be seeing more either mini-sabbaticals or long ‑‑ what we're thinking about is that people are meeting their PDUFA goals, their drug review goals, and they need to be rewarded, give them four to six weeks to go and do whatever they want to consider professional development, and keep it really broad and loose and let them pick their own avenue of development.
		We're also looking into virtual universities where we're talking training anyplace, anytime, web-based training.  And we have a couple what we call CRADA ‑‑ I don't know if anybody explained that.  I heard Peggy mention that term before, where we're partnering with private sector to try and bring courses that will develop the FDA training module, but then they'll make money by selling it to the industry.  So that we'll have some FDA information on the web that then they can go and make some money off the private sector.
		We're also trying to increase the attention we have in training the scientific community.  In the workforce development plan that we just did, one of the statements they made that, with just a 10 percent increase in the amount of money you spend on training.  So if we went from 1.3 to 1.43 percent of the money we spend on training you can get an 11 percent increase in productivity, and that was from the National Employee Survey, National Center on Education, Quality of the Workplace.
		So there is some justification to start spending a little more money on our employees.  Then the commissioner has a strong interest for FDA employees to go to external training, conferences, universities, to learn the state of the art of what's going on, so we know there's a commitment to further education right now.
		I did want to spend just a couple minutes on quality of work life.  An I ‑‑?
		DR. DAVIS:  Just 30 seconds on development?  Since it costs a lot of money to send a lot of people out, what about bringing people in?  How active are you in internal seminars --
		MS. BABCOCK:  Actually, I should have mentioned that.
		DR. DAVIS:  ‑‑ bringing in scientists to talk about state of the art stuff.
		MS. BABCOCK:  We have a lot of activity going on.  Almost all of our centers have some sort of staff college where they have speakers, either internal experts on particular ‑‑.  Our Center for Drugs, for instance, has almost a weekly seminar series that they put on, like on Wednesday afternoons.
		Our Center for Drug Evaluation and Devices have what they call grand rounds where they bring speakers from outside into the center, and then they pipe it out on their web, so everybody can get it on their desktop.
		So we're trying some different things with some improvement in technology and what have you.  So yes, we do that a lot.  We also, not too long ago, put together a package of collaborative efforts 
package of collaborative efforts between our centers.  Our centers have been accused of sort of being stovepipe organizations; and so in the training and organizational development community we put together a list of efforts that are going on, and it was quite an impressive package, over 150 examples of how we're collaborating within the organization.  And I think we'll continue to do more of that.
		In the quality of work life, this really was Secretary Shalala's initiative of several years ago where ‑‑ I think the theme of it is we really truly trust and believe in our employees, and if we believe in our employees, we're not going to have them signing in and out, we're not going to threaten them with reductions in force, we're not going to treat them like they're children.  We in fact are all going to pretend we're adults and behave that way.  
		But the truth of the matter is, we have like four cornerstones to the quality of work life effort.  The family-friendly with all the flexible work schedules, and we really have pushed that.  And I think even though our supervisors haven't embraced what I call the Any 80 program, they have embraced alternative work schedules and flexible hours in the morning and the afternoon, so that people can balance their family and work life.
		We do have a lot of people who take advantage of telecommuting centers and working at home, and we're trying to enhance that as soon as we figure out how to get security on the computer wires.  You know, we can let a drug reviewer go home for a month and do drug reviews, but it's the security of the information that we're concerned about.
		So a second part of the quality of work life is a learning organization where every employee has an opportunity to learn everything they want to learn.  If we're talking about rotating assignments, allowing people to experience new things in their careers, things that don't necessarily cost additional money, but where they can enhance their professional knowledge and development so that they do feel like they're getting new experiences in training.  So we're working a lot on that.
		Improving communication just within the organization.  You know, when  you have an organization of 10,000 people, just keeping everybody informed of what's going on is a big job.  So we're trying to figure out ways we can improve communicating within FDA, external to FDA, et cetera.
		Then the fourth part of it is appreciating diversity, making sure that every employee is ‑‑ takes full advantage of what they can do regardless of where they are in the organization, what their issues are; the more we know about each other, the better we can work together.
		So that's really our quality of work life in a real quick nutshell.  But we are trying to do some different things.
		I think the last slide I have is kind of the cornerstones of our workforce development, which ‑‑ our workforce strategic plan?  Yes, that one.
		[Slide] 
		If you can see that, like I said, we have contracted with Toffler & Martin.  I am really excited about where this project is going, and I think it's going the same direction that you all are talking about, coming up with new and different ways of recruiting and retaining employees, looking at the science base, looking at IT development to enhance our employees' capabilities.
		We really need to focus on leadership development.  Because we have been so short of resources, most of our money is spent on training in the science fields as opposed to training leaders in developing the supervisors and managers.  
		That's sort of a preview of coming attractions.  We're just finishing -- it's been about a three month effort now, and we've interviewed the entire top staff of FDA along with people in our industry, people in academia, employees, supervisors.  We've been to the field, we've been pretty much everywhere in the organization and I think we're ready to make a final presentation on it.  So I'm pretty excited about that.
		Thank you very much.
		DR. LANGER:  Thank you.  Comments?
		DR. SCHWETZ:  One last piece.  Bring this down to a real world example.  As I mentioned earlier, the Director of the Office of Premarket Approval within the Center for Food Safety and Applied Nutrition has an example that I want to have brought to you.  I looked around when we were planning this schedule, of who right now in the agency has the opportunity to do large hiring activity, to have that brought to you, to lay out for you the agenda, the plan for doing this, and with the prospect that this will come back in November and Alan will be able to tell us how well it has gone.  So you'll see it from the front and you'll see it in progress.
		We can talk about what things would be nice to do, but this is a real world example, and I'm hoping that it will help all of us.
		Alan?
	Hiring to support the Science Base of the CFSAN Food Ingredient Safety Program
		DR. RULIS:  Thank you, Bern.  Good afternoon, I'm Alan Rulis, I'm Director of the Office of Premarket Approval in the Center for Food Safety and Applied Nutrition.
		OPA is one of the two largest offices in CFSAN, and we do have a research component that does molecular biology research and chemistry research; but our primary goal, our primary responsibility is in the area of premarket approval for new food ingredients.
		What I want to talk to you this afternoon about very briefly is what is an almost unique opportunity for us; and that is the ability to hire a substantial number of new employees.  So in a sense we'll be focusing or putting sharp focus on some of the things we've had a discussion about earlier this afternoon.
		I just have a very few overheads, and the first one is up there now.  What I would like to do, this is a summary of what we're going to try to cover; talk a little about the Office of Premarket Approval, what it's like, what it is, what it does.  Mention that new targeted appropriations that we have at our disposal, talk a little bit about the current hiring initiative underway, and seek your help, essentially, in getting some ideas about how we can make that work for the long-term benefit of the center and for the agency. 
		[Overhead]
		The Office of Premarket Approval reviews petitions for new food additives, what we call direct food additives, artificial sweeteners, fat substitutes, anything that you can imagine that might be on the label of a food, a processed food.  We also work with color additives; not only color additives used in food but in medical devices and in other settings.
		We do premarket notification for food contact substances.  The statute defines food additives very broadly, and to include substances that might migrate into food from things that touch food, such as this bottle right here, for example, or a conveyor belt upon which a chicken might ride for a few seconds.
		A big program was put into effect in 1997 under FDAMA that created a premarket notification process rather than a petition process, but put an 120 day hammer on the process for FDA to review these applications.  In their wisdom, Congress did not effectuate that program without funds.  They said there will have to be funds to run this program, and they didn't come up for funds for the first two years.  But last year in October they did; came up with $6 million and said "Okay, run the program."  So we are starting that program now.
		We also do biotechnology consultations; this is for new plant varieties that are created using recombinant DNA biotechnology techniques; and we do what are called GRAS notifications.  There are a lot of ingredients in the food supply that are generally recognized as safe, and they're not food additives in the traditional sense but they do require some interaction with FDA.  And they're important components of the food supply and we spend a lot of effort doing those. 
		[Overhead]
		In round figures we have clusters, small, relatively speaking, small clusters of individuals working on these projects.  We have the category of people called consumer safety officers.  In our office they are more likely than not to be Ph.D. scientists in their own right.  Of these 30 or so staff-level people ‑‑ this does not include any supervisors or management, these are the actual workers, people.  About 21 or 22 of those 30 there have Ph.D.s in various fields; chemistry, biology, pharmacology.
		So they're scientists in their own right, but their real job is to manage the review of new food ingredient evaluations, safety evaluations.  So they have to essentially be able to talk with the scientists that are doing the reviews, and make sure, coordinate the review, make sure it's complete and accurate.  And then they have to write the regulation that puts that review into effect, and deal with attorneys and create a document essentially for the Federal Register for the public to read.
		We have chemistry reviewers whose job it is to ask, What is this additive that's going to go into food?  How pure does it have to be?  How much of this substance are people going to eat?  The toxicology reviewers, of course, are interested in what are the effects of this substance on a biological system.  And in particular human beings, although many of the studies we get are in rodents.
		And we have environmental reviewers because under the National Environmental Policy Act, we're required to substantiate that in any action that we take; we have taken care of the environmental aspects of it.  That's more important for packaging materials than it is for direct additives, but it is a factor.
		A large fraction of our employees are in fact doctorate-level people. 
		[Slide] 
		Now this is a slide that shows you what has happened to us since October of 1999.  In October of '99, Congress appropriated two, we consider them large sums of money; $6 million to run the premarket notification program for food contact substances, and $5.4 million to enhance, to speed up, to make more efficient, more effective, the review of direct food and color additive petitions.
		And under those two programs respectively, we see ourselves hiring about 30 new hires in the PMN area and about 20 new hires in the direct food and color additive area.
		This is an enormous opportunity for us; we have not had this happen for 20 years.  I am probably the beneficiary of the last large hiring in this area, that took place back in 1977.  And I'm getting a little bald and grey, so it's been a while.
		[Overhead]
		Now what we want to do, Dennis Keefe of my staff is with me, and I've charged Dennis with responsibility to set up a hiring program and to make this happen.  It is not a trivial matter.  Trying to deal with this kind of money in an instant is a little bit like drinking from a fire hose; you can't deal with it rapidly.  But we're trying to set up a program that will bring on these new employees and essentially build for the future, not just fill slots.
		So it goes back to our earlier discussion:  How do we ‑‑ what can we do to bring on the best possible employees for the future to build and strengthen our organization for the long term.
		Dennis will talk to you about what he's putting into place at the moment and then charge you with some questions about how you might be able to help us make this work.
		DR. KEEFE:  Thank you.  First I'd like to say that I think our office views this as a tremendous opportunity.  I cannot overemphasize this.  This is a once in a career opportunity for us, for me.  I've been with FDA for nine years now, and I've never seen anything like this.  This is great.  I'm very excited about it.
		This is going to give us a chance to take a proactive approach to our future, to strategically plan for the future of what we're going to look like for the next 20 years.  It's a substantial amount of money, so that we can -- this is a supercritical mass of money that allows us to think creatively, look for the future, and really plan what we're going to do.
		It also allows us to think outside of the box.  You heard a lot of discussion from Mary what we're doing, you've heard Dr. Suydam talk about things that the agency wants to do with leveraging; this is the nucleus for trying to implement some of these ideas on a grand scale.
		[Overhead]
		Our goal in recruitment is to recruit scientifically-sound scientists to do regulatory working the area of foods.  We want to target our equal employment goals, we want to use this to leverage our scientific expertise with non-FDA resources.  And we want to take a long-term approach to this recruiting and hiring.
		[Overhead]
		Some of the things we've done are the traditional recruiting.  We've got the OPM vacancy announcements out on the web page, and these are open until the end of May, and we were going through that sort of effort.  We've got the ads in the scientific journals, we're attending job fairs, we're identifying ones that will have the scientific expertise that we need.  We're attending scientific society meetings, we're advertising on employment web pages, we're sending letters to academic departments that are of interest.
		Some of you have been involved in recruiting on the industry side, and if you have ideas on how we can expand on these traditional approaches, we would love to hear them from you, if we could implement those.
		[Overhead]
		We're also trying to think outside the box, using nontraditional strategies.  Not only for recruiting but also to retain scientists and also develop interest on the outside in the scientific program, in the academic programs in FDA; make people aware of what we're doing.
		Because I can recall when I was an undergraduate, I had no idea what FDA did, and I'm not from this area; there's no reason for me to know what FDA does.
		And these are just ideas.  We did some brainstorming.  Is there a way we could set up a mentoring program with in-house FDA scientists with current graduate students or undergraduate students?  Would it be possible to develop some sort of food safety regulatory academic degree in collaboration with an academic institute?  Maybe the University of Maryland, maybe other universities, maybe nationally we could set up some sort of program.
		We talked a little bit about sabbatical programs here for FDA scientists.  How can we best do that?  How can we implement that in a targeted way that develops our scientific expertise in-house and promotes that, helps us retain scientists, but also gets the word out about what we're doing in FDA.  So scientists outside of FDA become aware of what we're doing, maybe become interested in becoming part of FDA.
		Leveraging, not an FDA resource.  You've heard about the JIFSAN program; that's really geared towards research. What we want to look at is from a regulatory scientist perspective; we can expand there.  We heard a little bit about special government employees; that might be one option.  
		I'm sure there's other ideas, and this is what we're looking for from you to help us think through this thing, through this strategically taking a long-term approach to what our needs are, to try to develop our programs and maintain our scientific expertise.
So that's my schpiel.
		DR. LANGER:  Alan, anything else?
		DR. RULIS:  No; I'll just turn it over to you.  We've been encouraged, in the earlier part of this afternoon, the discussion on some of the ideas that were coming forth about how it is clearly appreciated that we do face enormous challenge in bringing on the best and the brightest for the future in the FDA.  I think we're sensitive to that, but we're also appreciative to the sense that you are thinking about ways to solve that for us or give us ideas that may not be the first ones that come to our minds.  We're ready to listen and make the best use of it.
		DR. LANGER:  Okay.  Marion and Bob.
		DR. NESTLE:  The obvious one that leaps to mind is a traveling road show, where you go and visit the universities that are training large numbers of graduate students and have large numbers of postdocs, and meet with them personally and talk about what the opportunities are.
		I know people who'd come to work for FDA.  They didn't want to run their own research programs; they wanted to have something where ‑‑ where somebody paid their salary and they didn't have to get grants.
		That was a big ‑‑ and also, to put it another way, they'd be doing something that's really valuable, that has a value system attached to it.  I think that's a big selling point.  These are important responsibilities that serve the public and serve public health.  I would push it to the max.  It's true, it's real, there could be lots of people who want to do that, and go to the best universities.
		DR. SCOLNICK:  I agree with Marion.  I think you can make a program like that, because of the value system behind what you're doing is an important one that I think young people can identify with.  And if you put the time and effort into it, I think you can make it work.
		DR. LANGER:  I'm going to have Bob go next and then Harold; but just -- what companies do; like at M.I.T. they basically just come there for a couple of days and they spend a lot of time, interview people ‑‑ some companies actually have real programs with, where we get money obviously you can't do that.  But I mean you certainly can come for a day or two to a whole bunch, target a bunch of universities, like Bob was saying before. 
		I think if you send a couple people there for two or three days and I'm sure that the job placement offices at all these schools, you know, would welcome it.  I was amazed, even ‑‑ just to pick an example, I was on a review committee for Princeton, how they have all these people interested in the pharmaceutical industry, but you know a lot of companies don't come there because they're not that big in some of the ‑‑ I told this to Dr. Merck. 
		(Laughter) 
		DR. MERCK:  But I see no reason why FDA should be ‑‑ well, only because Merck is ‑‑ see it's amazing The reason I actually print that though, Merck is down the street.  They're not --
		DR. DAVIS:  They don't need any help.
		(Laughter) 
		DR. LANGER:  But Princeton needed it, so I was trying to help Princeton out.  But the point I'm making is that you could have ‑‑ you know, you could spend a couple days ‑‑ and it was only sending one or two people to these schools.
		Anyhow, Bob and then Harold.
		DR. NEREM:  I actually have some questions before I make a ‑‑ 
		DR. LANGER:  CalTech, I was going to tell you to do in.
		DR. NEREM:  As I understand it, FDA normally is going to hire about 500 a year.  So because of this extra money, it's going to hire 550.  So I guess the significance of this isn't so much the added people as the fact it's in a very focused area.
		And yet it's not clear to me that your recruiting strategy ought to be under that focus.  That's something that maybe ought to be discussed.
		The other question I had was, to what level are you looking?  Because I think that has to affect your recruiting strategy.  If you're looking at VSMS people, that's one thing.  If you're looking at Ph.D.s, that's another thing; and I almost got the impression you were looking for VSMS people since one of the fringe benefits you were running up there was some kind of a degree.
kind of a degree.  So.
		DR. KEEFE:  I guess for the most part as far as the recruiting, we're looking primarily for P.H.Ds and targeting on the new PH.D. because of the salary structure.
		What I was thinking, as far as the B.S.-M.S. program was long-term.  If there was an academic program that focuses on a regulatory scientist program, maybe it's not just FDA involvement.  Maybe this would involve the other food safety or regulatory agency, maybe; and the drug side of FDA.
		If there could be some, maybe a program at a local university, a degree, an M.S. on this; or it could be integrated nationally with an academic program.
		DR. NEREM:  Well, let me make my comments; and I can only speak on the context of Georgia Tech.  And Bob can speak in the context of M.I.T.  But at least that Georgia Tech, if you want to recreate at the B.S. level, you ought to be talking to the college placement office.  If you want to be recruiting at the Ph.D. level, you ought to be talking to the Research Institute and connecting there, one way to do that is number one, you've got to establish a relationship; offer to come in and give a seminar ‑‑ because that will give you great visibility and as was suggested by Bob, you know, following that seminar you stay around for a couple of days and ‑‑ you know, we're always ready to help our graduate students find jobs.
		DR. LANGER:  Harold, Ed, we'll go down the row.
		DR. DAVIS:  I keep the critical question is whether the job skills you're looking for these jobs.  Are you looking for people with an attrition background; could have Ph.D.s in anything, whatever.  I think that helps you to target what schools.
		I think in the sabbatical, putting your faculty, your members into certain universities to provide a six month, three month whatever, gives you an opportunity to be in a place for an extended period of time.  Three days is greater than recruiting; but if you could pick two or three schools that you really want to be present in, putting people in on a sabbatical.
		Another thing I think that works great is internships. If you bring people out of these programs, even if you're looking for Ph.D.s, if you bring people out of these undergraduate programs and want to get Ph.D.s, they start remembering you and thinking about you, et cetera.
		I don't know if the FDA or government can use headhunters.  Is that taboo?  Can you do that?  I know companies that have brought headhunters in, not just one at that time, but two or three or four at a time.  They have job fairs on your site so that they get to understand what the job is you're recruiting for, et cetera.  They get to see the working environment, et cetera, so that they become much more familiar with how you're going to use these people.  So they become I think more effective recruiters, instead of just dealing with one headhunter at a time.
		DR. LANGER:  Ed?
		DR. SCOLNICK:  Just two specific suggestions; one related to the issue of potentially a master's program of some kind.  You probably know, Temple University, which is down the street from one of our sites, runs a program for basically teaching people about the compliance issues at FDA.  And a place like that or other universities like that might be willing to have master's programs to fill some of the master's level needs that you have.  And I think getting in touch with the Temple School of Pharmacy that runs, gets a program on compliance, might give you some ideas on how to construct that kind of program.
		The second point, in terms of your going to universities and giving seminars.  Within whatever limits you're legally allowed to do this, the way to engage students is to talk to them about science.  And you do have these public meetings that are open information through FOI on drugs, and if somebody within a rational way can put a talk together that says, "Here's what we do.  Here's the science we reviewed.  Here are the issues we faced.  Here's how we resolved it scientifically."  So you give them a flavor scientifically of what it is the job is all about, and get them excited about that, you'll engage the students.
		If you go and tell them about government service, it's too dry.  Even though it is a nice thing to talk about, you won't attract them with that kind of approach, is the primary approach.
		DR. ROSENBERG:  I have a slightly different perspective.  Given that you have a focused program and you're talking about as many as 50 people, that provides a unique opportunity, actually, for attracting first a couple of people who were actually known or with some name recognition.  You've got a big enough program to actually ‑‑ it's not a one-off, it's not "Come here because I've got eight jobs to fill" and therefore you can't give them structure or actually provide them additional resources as you can when you start talking about having a reporting structure of maybe eight, ten people under somebody who you can now attract to a program.
		This gives you a chance to kind of use the advantage of going and picking a couple of key people with name recognition who would add to the whole presence of your organization, and they will end up being your recruiting capability.  They do the job because of their name recognition.  It only happens when you have enough resources to be able to attract a couple of people with that stature.  Now if that can be done in this area, I think there's a great opportunity for you to use that kind of strategy.
		DR. SCOLNICK:  I think it's a great idea.
		DR. LANGER:  Excellent.  Mike?
		DR. DOYLE:  This isn't a short term approach that you need, but long-term, I once had a student from Health Canada who was on their hook; they paid all the tuition and everything else for her to work with me for, I guess it was three or four years.  And she then had to work back two years for every year she was with me, with Health Canada.  But, you know, it's the opportunity for the agency to pick their best at the undergraduate level, send them on to graduate school and have them for a longer time.
		DR. LANGER:  Other suggestions or comments?
		Well, thank you.  Anything else on this topic?
		Then I guess we'll go to the final topic, which is concluding discussion, further direction for the Board.  We discussed some of this over lunch and I thought maybe what we could do was actually have Bern summarize some of the action items and see if anybody wants to add anything.
		DR. SCHWETZ:  This is being constructed on the fly so it will take a second to think about it, and be sure I'm saying what I think happened. 
		DR. LANGER:  People can correct it.
Concluding Discussion:  Further Direction for the Board
		DR. SCHWETZ:  In the context of the response by CFSAN, to the report of the review of CFSAN, Dr. Scolnick mentioned the benefit of having information on what's going on in the center related specifically to c.v.s for new recruits, information on publications and other documents that would have come out from the center staff, and examples or complete list of impacts that have come out of the work that's being done.  And if the board wants to expand that so that it's more than Dr. Scolnick's thoughts and adopt this as recommendation, it appeared to me that Joe and Bob were prepared to do that.  And I would like to see that happen as a model.
		DR. LANGER:  I think that everybody seemed to think it was a good idea.
		DR. SCOLNICK:  Yes, with a balanced view of what Harold said, there would have to be publications.
		DR. DAVIS:  Just impact work.  What have they been doing.
		DR. LANGER:  Yes.
		DR. NEREM:  Measures of impact.
		DR. LANGER:  So that will be a formal recommendation.  Good.
		DR. SCHWETZ:  One of the things that we talked about at noon, and we've got the specifics.  But the discussion on future directions in the Science Board and items that we could talk about where we would bring you particular issues or information for your response.  And we will include that list of topics from that discussion this noon.
		To capture your thoughts about the need for the agency to bring focus and priorities on the bigger picture of all that goes on.  And to use that as a basis then to overlay on priorities at the center level.  We tend to have priorities and plans at the center level, but we haven't very often captured those in a whole set of plans for the agency.
		One specific was that you accepted the peer review report of the review of CFSAN, and another specific of that was that Dr. Fennema and I were to talk about guidelines for future reviews.  Owen has already come up with a draft of that, which I will look at and give some more thought to and get back to you
		DR. FENNEMA:  It needs some more work on it yet.
		DR. SCHWETZ:  You did well in the short time that you had.  So we'll continue to work on that.
		There was a recommendation that there could be a position paper written by members of the Science Board on something as specific as GMO foods, and that Joe Levitt and I and Marion and Rita Colwell would get together by telephone and talk about what that might look like, and discuss the possibility that there would be a position paper that would come out on a topic that specific.  So we'll talk about that.
		DR. FENNEMA:  So we didn't talk about what would be done with that, once it was prepared.
		DR. LANGER:  I think we weren't even at that stage.  At this stage I think we want to just sort of map out a plan.  You know, get their advice on --
		DR. FENNEMA:  Before you do something, you ought to figure out how you're going to use it. 
		DR. LANGER:  I think that would be part of what they would come back with as a recommendation; that's what I meant.
		DR. FENNEMA:  All right.
		DR. LANGER:  I mean I agree with you, and I think ‑‑ but that would be part of what they would do.
		DR. FENNEMA:  Very good.
		DR. SCOLNICK:  One thought on that.  I really don't know whether anything has been done by now, but you might consider engaging the IOM in that activity because they're always ‑‑ there are views of an independent organization, and it's the kind of thing they like to do.
		So I don't know whether they've ever done on engineered foods or not, but just another thought.
		DR. NEREM:  May be another part of the National Research Council besides IOM that may be better equipped ‑‑.
		DR. SCOLNICK:  Yes.
		VOICE:  The NAS just did ‑‑
		DR. NEREM:  Yes, I don't know who --
		DR. LANGER:  It's a good suggestion and that's part of what could be incorporated into when they talk.
		DR. NEREM:  Yes.
		DR. SCHWETZ:  With regard to the Office of Women's Health presentation, the suggestion or the request of the volunteer was made that they will pull together information on the successes of their grant program, and primarily in the context of which of these have been a stepstone for larger projects that continued to get that kind of information, and use it as a basis for guidance for how they would provide support in the future.  
		And that they would, it be helpful if they spent some effort to define the border areas between the Office of Women's Health here and the Office of Women's Health in NIH, and the kinds of activities that they support.
		DR. NEREM:  I think the whole issue of one to two year grants versus longer projects needs to be addressed.
		DR. SCHWETZ:  Long-term commitment to fewer areas of effort.
		DR. NEREM:  Right.  With periodic peer review.
		DR. SCHWETZ:  Yes.  Those were these two that were here.  To maintain objectivity in the peer review process and develop longer-term plans.
		DR. LANGER:  And focus.
		DR. SCHWETZ:  And focus, yes.
		One of the things we will get back to you before the next meeting is some additional information ‑‑ Mary, you bailed us out on an organizational chart, but there must be other information that we can provide to you that will give you a little more background information on the agency, and we'll give some thought to how we could present information to you at the next Science Board meeting that would give you a better profile of what's going on in the agency.
		I would say though, that when we did this for the Science Board earlier on, we may have given too much information, because they had the feeling that we had a lot of dog and pony shows and no issues.  And we will keep it brief and targeted so that this doesn't go on for meeting after meeting after meeting and just get details of what's going on. 
		DR. LANGER:  I think part of the issue, too, was not just the organizational chart, but understanding how the different centers maybe interact with each other.  I think that was one of the things that came up.
		DR. SCHWETZ:  That would be part of it; but also if we can get you to understand what the issues are of a center, and in that context understand what the center is about, that's much better than simply telling you what the center does.  So we'll try to keep it issue-oriented.
		We do have recorded that Dr. Scolnick will make a presentation next time on global information gathering, and how that could be done in the context of the future for the agency. Is that ‑‑?
		DR. SCOLNICK:  Well, in terms of the review process.
		DR. SCHWETZ:  Yes.
		DR. SCOLNICK:  A global review process or concept.
		DR. SCHWETZ:  The idea of pursuing a public education for GMOs is something that we will look at as well.  
		And then some specifics about this recruitment and retention discussion this afternoon, to get you to continue to think about how you would do this if you were charged with what the employment list of the agency would look like in twenty years, to give us some additional thoughts from you on how you might do that; for us to get more involved in university programs, to have a larger presence in targeted university programs through sabbaticals and time spent there, in addition to more time spent recruiting on site.  To get our face in front of more potential employees.
		And Harold, your point is well taken that we will continue to look for historically black colleges and universities and to focus as much as we can there.  There's a very limited number of people who are available, and any help that we can get in knowing where else to go to keep turning over more stones to find good people, we would sure welcome that kind of help.
		Your note about talking science to the students and get them to understand the science as opposed to the 1906 law, I agree with that thought.
		DR. NEREM:  At the graduate level, those of us that have NIH training grants, we are continually responsible to NIH for showing how we're reaching out to produce a more diverse scientific community.  So generally those programs will have a reasonable number of underrepresented minorities in the graduate programs.
		DR. SCOLNICK:  I don't know how we would do this, but it's just a spontaneous thought, but you might be able to work out some rational way of doing it:  About two years ago, Merck gave a substantial sum to UNCF to try to foster fellowships for minorities; a variety of schools, both small schools and large schools.  And we have a fairly organized program now that involves doing that and recruiting from that talent pool.  There's no way we will attract those people nor are there enough jobs.  If there were some way we could plug you into that program ‑‑ I don't think there would be any real conflict of interest there.  I don't know how we would do it logistically, but if you want me to look into it and then I guess you'd be the contact?
		MS. BABCOCK:  Yes.
		DR. SCOLNICK:  I'll have somebody get in touch with you.  Maybe there's something we can do to be helpful.
		MS. BABCOCK:  Okay.
		DR. NEREM:  Are people with those fellowships, is that public knowledge?
		DR. SCOLNICK:  Right.  Oh, yes, it's public knowledge.  Yes, it's a completely public program.  There's nothing here that's a conflict of interest in any way, shape or manner.
		And we could make sure if there was some ‑‑ you know, we can take care of whatever issues there are.
		DR. SCHWETZ:  There were some additional recommendations in this context of being more involved with universities, internship programs, things of that kind.  Trying to focus more on job contentment and what it's like to be a government employee, to work in public service.
		There's a former consultant to ours who is helping you with various meetings and things who is writing a book and has interviewed many of us in the FDA, and asking us "why did you continue to work for the FDA as long as you did?"  To try to capture what there is among long-term happy government employees that might be the kind of message we would want to give in a recruitment activity about ‑‑ you know, everybody doesn't work for the government just for a few days and get out.
		So I think there are some things to be said for why there are a lot of good people who do work for the government for a long time and are happy about it.  
		So that, Bob, captures I think a lot of what ‑‑.
		DR. LANGER:  The other one that I had ‑‑ something to the effect that in the dietary supplements strategy plan, I think there were some concerns about it being, certain things maybe being a little vague and maybe trying to focus in on that.  I don't know if we took anything down to ‑‑ [Remark to Mrs. Bond]
		Okay.  Is there anything else anybody would want to add for other things we might do in the future?
		Maybe I'll just make a couple of closing comments.  I just wanted to say, just from my standpoint as chair, I thought that the thought FDA presentations were terrific, right to the point, very provocative, and having sat through a number of science boards and been on a number of different science boards, this is by far the best one I've been on.  You guys all, the women all did a fantastic job.  Lots of great questions, lots of great comments.  I really appreciate it, and I think hopefully it will augur well for the future.
		So I guess ‑‑ do we have a motion to adjourn, or do you want to say anything else?
		DR. SCHWETZ:  I would like to reinforce that we're looking forward to good leadership.  If this is the beginning of a new plane, this is wonderful.  This has clearly been a very useful meeting for us and we really appreciate the level of interaction that you've provided for us.  Thank you very much.
		DR. LANGER:  So we have a motion to adjourn? 
		(Laughter) 
		DR. LANGER:  Okay.  I think that will pass pretty quickly.
	[Whereupon, at 2:40 p.m., the meeting adjourned.]
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